Trial Outcomes & Findings for A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM) (NCT NCT04776018)

NCT ID: NCT04776018

Last Updated: 2024-10-02

Results Overview

TEAEs were adverse events (AEs) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 27 participants
• Primary outcome timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months)
• Results posted on: 2024-10-02

Participant Flow

Participants took part in the study at 10 investigative sites in the United States and Canada from 20 April 2021 to 09 November 2023. Participants with diagnosis of Relapsed and/or Refractory Multiple Myeloma (RRMM) were enrolled in Phase 1b Part 1 to receive TAK-981 in combination with mezagitamab.

This study consisted of Phase 1b and 2. Phase 1b (Dose Escalation) had two parts (Parts 1 and 2) and Phase 2 (Dose Expansion) was single part. Phase 1b- Part 2 and Phase 2 were not conducted, as study was terminated early after completion of Phase 1b Part 1 due to business reasons and therefore, no data for Phase 1b Part 2 and Phase 2 was collected and reported.

Participant milestones

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg Participants received TAK-981 60 milligrams (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly (QW) on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 2: TAK-981 + Daratumumab + Hyaluronidase-fihj Participants were planned to receive TAK-981, infusion, intravenously, in combination with daratumumab and hyaluronidase-fihj, injection, subcutaneously, once weekly in Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 1b, Part 2.	Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 2.
Overall Study STARTED	3	3	10	3	8	0	0
Overall Study COMPLETED	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	3	3	10	3	8	0	0

Reasons for withdrawal

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg Participants received TAK-981 60 milligrams (mg), infusion, intravenously, twice weekly (BIW) on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly (QW) on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 2: TAK-981 + Daratumumab + Hyaluronidase-fihj Participants were planned to receive TAK-981, infusion, intravenously, in combination with daratumumab and hyaluronidase-fihj, injection, subcutaneously, once weekly in Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 1b, Part 2.	Phase 2: TAK-981 (RP2D) + Selected Anti-CD38 Antibody Participants were planned to receive TAK-981 recommended phase 2 dose (RP2D), infusion, intravenously, in combination with an anti-CD38 antibody (mezagitamab or daratumumab and hyaluronidase-fihj), injection, subcutaneously, for up to 24 cycles or until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days. No participants were enrolled in this arm as this study was terminated early before start of enrolment in Phase 2.
Overall Study Death	0	1	4	1	4	0	0
Overall Study Study terminated by sponsor	2	1	4	0	3	0	0
Overall Study Withdrawal by Subject	1	0	0	2	1	0	0
Overall Study Other	0	1	1	0	0	0	0
Overall Study Lost to Follow-up	0	0	1	0	0	0	0

Baseline Characteristics

A Study Of TAK-981 Given With Monoclonal Antibodies (mAbs) In Adults With Relapsed or Refractory Multiple Myeloma (RRMM)

Baseline characteristics by cohort

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Total n=27 Participants Total of all reporting groups
Age, Continuous	61.0 years STANDARD_DEVIATION 19.29 • n=5 Participants	65.0 years STANDARD_DEVIATION 4.58 • n=7 Participants	66.2 years STANDARD_DEVIATION 12.97 • n=5 Participants	74.0 years STANDARD_DEVIATION 4.00 • n=4 Participants	71.9 years STANDARD_DEVIATION 3.94 • n=21 Participants	68.0 years STANDARD_DEVIATION 10.52 • n=10 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	8 Participants n=10 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	19 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants	25 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=10 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	19 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months)

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

TEAEs were adverse events (AEs) that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. Adverse event (AE) means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: Number of Participants With One or More Treatment Emergent Adverse Events (TEAEs)	3 Participants	3 Participants	10 Participants	3 Participants	8 Participants

PRIMARY outcome

Timeframe: From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months)

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

The severity grade was evaluated as per the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0, except for Cytokine Release Syndrome (CRS), which was assessed by American Society for Transplantation and Cellular Therapy (ASTCT) consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living (ADL), Grade 4 was 4 Life-threatening consequences; urgent intervention indicated. and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: Number of Participants With Grade 3 or Higher TEAEs	0 Participants	3 Participants	7 Participants	3 Participants	7 Participants

PRIMARY outcome

Timeframe: Cycle 1 (Cycle length = 28 Days)

Population: DLT-evaluable analysis set included participants who received at least 75 precent (%) of planned TAK-981 doses, all mAb doses, and have completed Cycle 1 procedures, or experienced a DLT in Cycle 1 in the phase 1 portion of the trial.

DLTs were evaluated according to NCI CTCAE version 5.0. Grade 5 AE. Hematologic toxicity: Nonfebrile Grade 4 neutropenia/Grade greater than or equal to (>=) 3 febrile neutropenia; Significant Grade 3 thrombocytopenia; Grade 4 anemia or thrombocytopenia. Nonhematologic Grade 3 or higher toxicities; Grade 2 nonhematologic toxicities leading to dose reduction/discontinuation. Delay in Cycle 2 by greater than (>) 14 days or missed >1 planned doses of TAK-981/monoclonal antibody (mAb) in Cycle 1 due to TEAEs.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=7 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: Number of Participants With Dose Limiting Toxicities (DLTs) Based on NCI CTCAE Version 5.0	0 Participants	0 Participants	1 Participants	1 Participants	1 Participants

PRIMARY outcome

Timeframe: From date of treatment start to until date of first PD or death (whichever occurred first), up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

ORR: percentage of participants who achieve complete response (CR) or partial response (PR) or better per investigator assessment by IMWG.CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5 percent (%) plasma cells in bone marrow (BM). PR: >50 percent (%) reduction of serum M-protein and reduction in 24 hours (h) urinary M-protein by >90% or to less than (<) 200 milligrams per 24 hour (mg/24 h); If serum and urine M-protein were unmeasurable, >50% decrease in difference between involved and uninvolved free light chain (FLC) levels was required in place of M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was >30%. In addition to the above listed criteria, if present at baseline, a >50% reduction in the size of soft tissue plasmacytomas is also required.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Cycle 1 Day 1: Pre-dose, at end of infusion (EOI), 2, 4, 6, and 24 hours post-dose; Cycle 1 Days 8 and 15: Pre-dose and EOI; Cycle 2 Days 1 and 15: Pre-dose and EOI (Cycle length = 28 days)

Population: Pharmacokinetic (PK) analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "number analyzed" signifies participants evaluable at specified time-point.

Observed plasma concentration of TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 15: EOI	281 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 38.1	585 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.8	812 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 55.5	830 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	940 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 24.6
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 1: Predose	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 1: EOI	225 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 44.3	642 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	617 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 61.7	1120 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	842 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.5
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 1: 2 hours	79.4 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 51.7	110 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 27.8	115 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 49.3	139 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 47.9	116 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 38.3
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 1: 4 hours	37.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 45.7	63.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 37.3	69.6 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 62.3	63.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 18.9	56.5 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 38.9
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 1: 6 hours	31.0 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 65.4	33.2 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	—	—	—
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 1: 24 hours	3.27 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 68.3	5.91 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 12.9	4.75 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 54.0	5.51 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.2	6.29 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 57.7
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 8: Predose	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	0.519 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 62.6	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	0.411 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 78.8	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 8: EOI	318 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 84.6	576 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 17.1	829 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 52.7	1360 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 41.1	1070 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 45.4
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 1 Day 15: Predose	0.177 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 28.8	0.758 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 1139.8	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 2 Day 1: Predose	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 2 Day 1: EOI	212 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 13.1	844 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 38.5	767 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 61.6	1580 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	820 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 8.7
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 2 Day 15: Predose	0.182 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 34.9	0.536 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	0.286 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	NA nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: Observed Plasma Concentration of TAK-981 Cycle 2 Day 15: EOI	191 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	—	634 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 46.3	1500 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	713 nanograms per milliliter (ng/mL) Geometric Coefficient of Variation 14.2

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Cmax for TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=9 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=6 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1, Cmax: Maximum Observed Plasma Concentration for TAK-981	225 ng/mL Geometric Coefficient of Variation 44.3	642 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	617 ng/mL Geometric Coefficient of Variation 61.7	1120 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	842 ng/mL Geometric Coefficient of Variation 27.5

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Tmax for TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=9 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=5 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for TAK-981	0.97 hours Interval 0.92 to 1.02	1.12 hours Interval 1.12 to 1.12	1.09 hours Interval 1.0 to 1.25	1.09 hours Interval 1.09 to 1.09	1.15 hours Interval 1.09 to 1.25

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

AUC0-t for TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=5 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1, AUC0-t: Area Under the Plasma Concentration-time Curve From Time 0 to Time t for TAK-981	813 hours*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 30.4	1550 hours*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	1590 hours*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 33.9	2120 hours*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	1690 hours*nanogram per milliliter (h*ng/mL) Geometric Coefficient of Variation 19.8

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

AUC0-inf for TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=7 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=4 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1, AUC0-inf: Area Under the Plasma Concentration-time Curve From Time 0 to Infinity for TAK-981	839 h*ng/mL Geometric Coefficient of Variation 32.5	1590 h*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	1590 h*ng/mL Geometric Coefficient of Variation 36.1	2180 h*ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	1690 h*ng/mL Geometric Coefficient of Variation 22.2

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

t1/2z for TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=7 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=4 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1, t1/2z: Terminal Disposition Phase Half-life for TAK-981	5.24 hours Interval 4.84 to 5.65	5.25 hours Interval 5.25 to 5.25	4.96 hours Interval 4.75 to 6.23	5.33 hours Interval 5.33 to 5.33	5.49 hours Interval 5.09 to 5.84

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

CL for TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=7 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=4 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1, CL: Total Clearance for TAK-981	71.5 liters per hour (L/h) Geometric Coefficient of Variation 32.5	56.5 liters per hour (L/h) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	56.7 liters per hour (L/h) Geometric Coefficient of Variation 36.1	55.0 liters per hour (L/h) Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	71.2 liters per hour (L/h) Geometric Coefficient of Variation 22.2

SECONDARY outcome

Timeframe: Cycle 1 Day 1: pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: PK analysis set included participants with sufficient dosing and PK data to reliably estimate 1 or more PK parameters. Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.

Vss for TAK-981 was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=7 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=4 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1, Vss: Volume of Distribution at Steady State for TAK-981	377 liters Geometric Coefficient of Variation 5.1	281 liters Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	250 liters Geometric Coefficient of Variation 49.0	259 liters Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be estimated due to insufficient number of participants available for analysis.	331 liters Geometric Coefficient of Variation 20.4

SECONDARY outcome

Timeframe: Baseline up to 12 months

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

ADA positive was defined as participants who had confirmed positive ADA status in at least 1 post-baseline assessments. >=5-fold in ADA titer was defined as increase in the ADA titer value post-baseline of at least 5-fold from the positive ADA titer value at baseline.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: Number of Participants With Positive Anti-drug Antibodies (ADA) for TAK-981 + Mezagitamab and >= 5-fold in ADA Titer Participants with Positive ADA	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants
Phase 1b, Part 1: Number of Participants With Positive Anti-drug Antibodies (ADA) for TAK-981 + Mezagitamab and >= 5-fold in ADA Titer Participants with >=5-fold in ADA titer	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Cycles 1, 2, 3, 4, 6, 7 and 12: Day 1 pre-dose and at multiple timepoints (up to 24 hours) post-dose (Cycle length = 28 days)

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug. Here "number analyzed" signifies participants evaluable at specified time-point.

Observed serum concentrations of mezagitumab was reported.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: Serum Concentration of Mezagitamab Cycle 1 Day 1	NA ng/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA ng/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA ng/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA ng/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).	NA ng/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below lower limit of quantification (LLOQ).
Phase 1b, Part 1: Serum Concentration of Mezagitamab Cycle 2 Day 1	99400 ng/mL Geometric Coefficient of Variation 38.1	103000 ng/mL Geometric Coefficient of Variation 50.9	81800 ng/mL Geometric Coefficient of Variation 53.3	64900 ng/mL Geometric Coefficient of Variation 59.4	29000 ng/mL Geometric Coefficient of Variation 6634.0
Phase 1b, Part 1: Serum Concentration of Mezagitamab Cycle 12 Day 1	NA ng/mL Geometric Coefficient of Variation NA Geometric Mean and Geometric Coefficient of Variation could not be calculated because the values were below LLOQ.	—	—	—	—
Phase 1b, Part 1: Serum Concentration of Mezagitamab Cycle 3 Day 1	95500 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	200000 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	68400 ng/mL Geometric Coefficient of Variation 337.7	146000 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	154000 ng/mL Geometric Coefficient of Variation 94.7
Phase 1b, Part 1: Serum Concentration of Mezagitamab Cycle 4 Day 1	94500 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	—	—	—	—
Phase 1b, Part 1: Serum Concentration of Mezagitamab Cycle 6 Day 1	38400 ng/mL Geometric Coefficient of Variation 83.9	27000 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	101000 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	—	117000 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.
Phase 1b, Part 1: Serum Concentration of Mezagitamab Cycle 7 Day 1	71900 ng/mL Geometric Coefficient of Variation NA Geometric Coefficient of Variation could not be calculated due to insufficient number of participants.	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study drug until first disease progression (PD) or death, whichever occurred first (up to 12 months)

Population: Response-evaluable analysis set included participants with measurable disease at baseline and at least 1 posttreatment evaluation.

ORR: percentage of participants who achieve complete response (CR) or partial response (PR) or better per investigator assessment by IMWG.CR: Negative immunofixation on serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in bone marrow (BM). PR: >50 percent (%) reduction of serum M-protein and reduction in 24 hours (h) urinary M-protein by >90% or to less than (<) 200 milligrams per 24 hour (mg/24 h); If the serum and urine M-protein were unmeasurable, >50% decrease in the difference between involved and uninvolved free light chain (FLC) levels was required in place of M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was >30%. In addition to the above listed criteria, if present at baseline, a >50% reduction in the size of soft tissue plasmacytomas is also required.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=9 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=6 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: ORR Based on International Myeloma Working Group (IMWG) Criteria	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 70.8	0.0 percentage of participants Interval 0.0 to 33.6	0.0 percentage of participants Interval 0.0 to 70.8	16.7 percentage of participants Interval 0.4 to 64.1

SECONDARY outcome

Timeframe: From first dose of study drug until PD or death, whichever occurred first (up to 12 months)

Population: Response-evaluable analysis set included participants with measurable disease at baseline and at least 1 posttreatment evaluation.

CBR: % of participants with response of at least stable disease (SD) for >=3 months or better (stringent CR [sCR], immunophenotypic CR [iCR], molecular CR [mCR], CR, very good partial response [VGPR], PR, minimal response [MR] or SD) per investigator assessment by IMWG. sCR: CR plus normal FLC ratio, absence of clonal cells in BM. iCR: sCR plus absence of phenotypical aberrant plasma in BM with minimum of 1 million total BM cells. mCR: CR plus negative allele-specific oligonucleotide polymerase chain reaction. CR: Negative immunofixation on serum, urine, disappearance soft tissue plasmacytomas, <5% plasma cells in BM. VGPR: Serum, urine M-protein detectable by immunofixation but not on electrophoresis or >90% reduction in serum M-protein+urine M-protein level <100mg/24h. PR: >50% reduction of serum M-protein and in 24h urinary M-protein by >90% or to <200mg/24h. MR: >=25% but <=49% reduction in serum M-protein, reduction in 24h urine M-protein by 50 to 89%. SD: No CR, VGPR, PR or PD.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=9 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=6 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phases 1b, Part 1: Clinical Benefit Rate (CBR) Based on IMWG Criteria	66.7 percentage of participants Interval 9.4 to 99.2	33.3 percentage of participants Interval 0.8 to 90.6	11.1 percentage of participants Interval 0.3 to 48.2	0.0 percentage of participants Interval 0.0 to 70.8	33.3 percentage of participants Interval 4.3 to 77.7

SECONDARY outcome

Timeframe: From first documented confirmed CR or PR until first documentation of PD or death, whichever occurred first (up to 12 months)

Population: Response-evaluable analysis set included participants with measurable disease at baseline and at least 1 posttreatment evaluation. Here, 'overall number of participants analyzed' signifies participants who had CR or PR.

DOR was defined as a time from date of first documentation of a PR or better to the date of first documentation of PD based on IMWG criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM. PR: >50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to <200 mg/24 h; If the serum and urine M-protein were unmeasurable, a >50% decrease in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was >30%. In addition to the above listed criteria, if present at baseline, a >50% reduction in the size of soft tissue plasmacytomas is also required. DOR was calculated for those participants with a confirmed PR or CR.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=1 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phase 1b, Part 1: Duration of Response (DOR) Based on IMWG Criteria	—	—	—	—	3.2 months Upper and lower limit of 95% confidence internal (CI) could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From first dose of study drug to the date of the first documentation of PD or death, whichever occurred first (up to 12 months)

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

TTP: time from date of first dose to date of first documentation of PD as defined by standard disease criteria. PD was defined as increase of >25% from lowest response value in any one or more of following: a) Serum M-component and/or (the absolute increase must be >0.5 grams per deciliter [g/dL]). b) Urine M-component and/or (the absolute increase must be >200 mg/24 h). c) Only in participants without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 milligrams per deciliter (mg/dL). d) Bone marrow plasma cell percentage; the absolute percentage must be >10%. e) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. f) Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 millimoles per liter [mmol/L]) that can be attributed solely to the plasma cell proliferative disorder.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phases 1b, Part 1: Time to Progression (TTP) Based on IMWG Criteria	7.9 months Interval 5.7 to Upper limit of 95% CI could not be estimated due to insufficient events.	1.0 months Interval 1.0 to Upper limit of 95% CI could not be estimated due to insufficient events.	1.2 months Interval 1.0 to 2.7	1.6 months Interval 1.2 to Upper limit of 95% CI could not be estimated due to insufficient events.	3.7 months Interval 2.4 to Upper limit of 95% CI could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From the date of first dose of study drug to the date of the first dose initiation of the next line of antineoplastic therapy (up to 12 months)

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

TTNT was defined as the time from the date of first dose to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phases 1b, Part 1: Time to Next Treatment (TTNT)	10.6 months Interval 8.6 to Upper limit of 95% CI could not be estimated due to insufficient events.	5.2 months Interval 2.4 to Upper limit of 95% CI could not be estimated due to insufficient events.	1.6 months Interval 1.5 to 6.2	NA months Interval 2.1 to Median and Upper limit of 95% CI could not be estimated due to insufficient events.	6.3 months Interval 1.9 to Upper limit of 95% CI could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: From the first dose of study drug to date of PD or death, whichever occurred first (up to 12 months)

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

PFS was defined as time from the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first. PD was defined as increase of >25% from lowest response value in any one or more of the following: a) Serum M-component and/or (the absolute increase must be >0.5 g/dL). b) Urine M-component and/or (the absolute increase must be >200 mg/24h). c) Only in participants without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. d) Bone marrow plasma cell percentage; the absolute percentage must be >10%. e) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. f) Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phases 1b, Part 1: Progression-free Survival (PFS) Based on IMWG Criteria	7.9 months Interval 5.7 to Upper limit of 95% CI could not be estimated due to insufficient events.	1.0 months Interval 1.0 to Upper limit of 95% CI could not be estimated due to insufficient events.	1.2 months Interval 1.0 to 2.7	1.6 months Interval 1.2 to Upper limit of 95% CI could not be estimated due to insufficient events.	3.7 months Interval 2.4 to 5.6

SECONDARY outcome

Timeframe: From date of first dose of study drug up to death from any cause (up to 27 months)

Population: Safety analysis set included participants who received at least 1 dose, even if incomplete, of study drug.

OS was defined as the time from the date of first dose to the date of death. OS was analyzed using Kaplan-Meier (KM) method. Participants were followed for survival after the last dose of study drug.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phases 1b, Part 1: Overall Survival (OS)	NA months Median and upper and lower limit of 95% CI could not be estimated due to insufficient events.	NA months Interval 7.2 to Median and upper limit of 95% CI could not be estimated due to insufficient events.	13.8 months Interval 10.9 to Upper limit of 95% CI could not be estimated due to insufficient events.	10.3 months Upper limit and lower limit of 95% CI could not be estimated due to insufficient events.	11.0 months Interval 6.5 to Upper limit of 95% CI could not be estimated due to insufficient events.

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 1, 4, and 24 hours post-dose; Cycle 1 Day 8: Pre-dose, and 1 hour post-dose; Cycle 1 Day 15: Pre-dose (Cycle length = 28 days)

Population: Pharmacodynamic analysis set included participants who provided evaluable blood samples (Cycle 1 Day 1 predose sample and at least 1 postdose sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and here, "number analyzed" signifies participants evaluable at specified time-points.

Blood samples were collected to assess TAK-981-SUMO adduct formation. TAK-981-SUMO adduct formation in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing the TAK-981-SUMO adduct formation during the inhibition of the SUMO-activating enzyme by TAK-981.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=6 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=5 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phases 1b, Part 1: Fold Change From Baseline in Level of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 1: 4 hour post-dose	—	4.3 fold change Standard Deviation NA Standard Deviation could not be estimated due to insufficient number of participants available for analysis.	3.7 fold change Standard Deviation 1.47	4.0 fold change Standard Deviation 0.14	4.1 fold change Standard Deviation 1.06
Phases 1b, Part 1: Fold Change From Baseline in Level of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 1: 24 hour post-dose	2.4 fold change Standard Deviation 1.12	3.8 fold change Standard Deviation 0.65	2.2 fold change Standard Deviation 0.62	3.5 fold change Standard Deviation NA Standard Deviation could not be estimated due to insufficient number of participants available for analysis.	4.4 fold change Standard Deviation 1.60
Phases 1b, Part 1: Fold Change From Baseline in Level of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 8: 1 hour post-dose	3.5 fold change Standard Deviation 0.03	4.0 fold change Standard Deviation 1.18	6.0 fold change Standard Deviation 2.83	4.1 fold change Standard Deviation 0.35	5.6 fold change Standard Deviation 1.12
Phases 1b, Part 1: Fold Change From Baseline in Level of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 1: 1 hour post-dose	4.3 fold change Standard Deviation 0.81	5.1 fold change Standard Deviation 1.00	3.9 fold change Standard Deviation 2.63	5.7 fold change Standard Deviation 2.11	6.1 fold change Standard Deviation 4.14
Phases 1b, Part 1: Fold Change From Baseline in Level of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 8: Pre-dose	1.6 fold change Standard Deviation 0.01	2.5 fold change Standard Deviation 0.30	1.8 fold change Standard Deviation 0.78	2.4 fold change Standard Deviation 0.07	2.2 fold change Standard Deviation 0.39
Phases 1b, Part 1: Fold Change From Baseline in Level of TAK-981-Small Ubiquitin-like Modifier (TAK-981-SUMO) Adduct Formation in Peripheral Blood Lymphocytes Cycle 1 Day 15: Pre-dose	—	—	1.4 fold change Standard Deviation 0.61	2.8 fold change Standard Deviation NA Standard Deviation could not be estimated due to insufficient number of participants available for analysis.	2.3 fold change Standard Deviation 0.89

SECONDARY outcome

Timeframe: Cycle 1 Day 1: 1, 4, and 24 hours post-dose; Cycle 1 Day 8: Pre-dose, and 1 hour post-dose; Cycle 1 Day 15: Pre-dose (Cycle length = 28 days)

Population: Pharmacodynamic analysis set included participants who provided evaluable blood samples (Cycle 1 Day 1 predose sample and at least 1 postdose sample). Here "overall number of participants analyzed" signifies participants who were evaluable for this outcome measure and here, "number analyzed" signifies participants evaluable at specified time-points.

Blood samples were collected to assess SUMO inhibition. SUMO pathway inhibition in peripheral blood lymphocytes was tested by flow cytometry with an antibody recognizing SUMO-2/3 chains.

Outcome measures

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 Participants Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=6 Participants Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=2 Participants Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=6 Participants Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Phases 1b, Part 1: Fold Change From Baseline in SUMO Pathway Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 1: 1 hour post-dose	0.8 fold change Standard Deviation 0.14	0.5 fold change Standard Deviation 0.08	0.7 fold change Standard Deviation 0.30	0.5 fold change Standard Deviation 0.16	1.3 fold change Standard Deviation 1.51
Phases 1b, Part 1: Fold Change From Baseline in SUMO Pathway Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 1: 4 hour post-dose	—	0.6 fold change Standard Deviation NA Standard deviation could not be estimated due to insufficient number of participants available for analysis.	0.6 fold change Standard Deviation 0.29	0.9 fold change Standard Deviation 0.03	0.7 fold change Standard Deviation 0.30
Phases 1b, Part 1: Fold Change From Baseline in SUMO Pathway Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 1: 24 hour post-dose	0.7 fold change Standard Deviation 0.08	0.6 fold change Standard Deviation 0.01	0.7 fold change Standard Deviation 0.20	0.8 fold change Standard Deviation NA Standard deviation could not be estimated due to insufficient number of participants available for analysis.	1.6 fold change Standard Deviation 1.85
Phases 1b, Part 1: Fold Change From Baseline in SUMO Pathway Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 8: Pre-dose	0.6 fold change Standard Deviation 0.42	0.6 fold change Standard Deviation 0.24	0.8 fold change Standard Deviation 0.23	0.6 fold change Standard Deviation 0.58	1.5 fold change Standard Deviation 1.09
Phases 1b, Part 1: Fold Change From Baseline in SUMO Pathway Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 8: 1 hour post-dose	0.4 fold change Standard Deviation 0.25	0.3 fold change Standard Deviation 0.19	0.6 fold change Standard Deviation 0.61	0.4 fold change Standard Deviation 0.29	1.3 fold change Standard Deviation 1.56
Phases 1b, Part 1: Fold Change From Baseline in SUMO Pathway Inhibition in Peripheral Blood Lymphocytes Cycle 1 Day 15: Pre-dose	—	—	0.5 fold change Standard Deviation 0.39	0.8 fold change Standard Deviation NA Standard deviation could not be estimated due to insufficient number of participants available for analysis.	4.0 fold change Standard Deviation 5.38

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug. AE means any untoward medical occurrence in a participant administered a pharmaceutical product. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product. The severity grade was evaluated as per the NCI CTCAE Version 5.0, except for CRS, which was assessed by ASTCT consensus grading. Where Grade 3 was severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL, Grade 4 was 4 Life-threatening consequences; urgent intervention indicated. and Grade 5 was death related to AE. TEAEs were AEs that occurred after administration of the first dose of any study drug and through 30 days after the last dose of any study drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

CBR: percentage of participants with response of at least (SD for >=3 months or better sCR, iCR, mCR, CR, very good partial response [VGPR], PR, minimal response [MR] or SD) per investigator assessment by IMWG. sCR: CR plus normal FLC ratio, absence of clonal cells in BM. iCR: sCR plus absence of phenotypical aberrant plasma in BM with minimum of 1 million total BM cells. mCR: CR plus negative allele-specific oligonucleotide polymerase chain reaction. CR: Negative immunofixation on serum, urine, disappearance soft tissue plasmacytomas, <5% plasma cells in BM. VGPR: Serum, urine M-protein detectable by immunofixation but not on electrophoresis or >90% reduction in serum M-protein+urine M-protein level <100mg/24h. PR: >50% reduction of serum M-protein and in 24h urinary M-protein by >90% or to <200mg/24h. MR:>=25% but <=49% reduction in serum M-protein, reduction in 24h urine M-protein by 50 to 89%. SD: No CR, VGPR, PR or PD.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

DOR was defined as a time from date of first documentation of a PR or better to the date of first documentation of PD based on IMWG criteria. CR: Negative immunofixation on the serum and urine and disappearance of any soft tissue plasmacytomas and <5% plasma cells in BM. PR: >50% reduction of serum M-protein and reduction in 24 hours urinary M-protein by >90% or to <200 mg/24 h; If the serum and urine M-protein were unmeasurable, a >50% decrease in the difference between involved and uninvolved FLC levels was required in place of the M-protein criteria; If serum and urine M-protein are not measurable, and serum free light assay was also not measurable, >50% reduction in plasma cells is required in place of M-protein, provided baseline BM plasma cell percentage was >30%. In addition to the above listed criteria, if present at baseline, a >50% reduction in the size of soft tissue plasmacytomas is also required.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

TTP: time from date of first dose to date of first documentation of PD as defined by standard disease criteria. PD was defined as increase of >25% from lowest response value in any one or more of following: a) Serum M-component and/or (the absolute increase must be >0.5 grams per deciliter [g/dL]). b) Urine M-component and/or (the absolute increase must be >200 mg/24 h). c) Only in participants without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 milligrams per deciliter (mg/dL). d) Bone marrow plasma cell percentage; the absolute percentage must be >10%. e) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. f) Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

TTNT was defined as the time from the date of first dose to the date of the first dose initiation of the next line of antineoplastic therapy, for any reason.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

PFS was defined as time from the date of the first dose administration to the date of first documentation of PD or death due to any cause whichever occurs first. PD was defined as increase of >25% from lowest response value in any one or more of the following: a) Serum M-component and/or (the absolute increase must be >0.5 g/dL). b) Urine M-component and/or (the absolute increase must be >200 mg/24h). c) Only in participants without measurable serum and urine M-protein levels; the difference between involved and uninvolved FLC levels. The absolute increase must be >10 mg/dL. d) Bone marrow plasma cell percentage; the absolute percentage must be >10%. e) Definite development of new bone lesions or soft tissue plasmacytomas or definite increase in the size of existing bone lesions or soft tissue plasmacytomas. f) Development of hypercalcaemia (corrected serum calcium >11.5 mg/dL or 2.65 mmol/L) that can be attributed solely to the plasma cell proliferative disorder.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

OS was defined as the time from the date of first dose to the date of death.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 24 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 12 months

Population: The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 2 part of the study. Hence, the data for this outcome measure could not collected, analyzed and reported.

Outcome measures

Outcome data not reported

Adverse Events

Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg

Serious events: 4 serious events

Other events: 10 other events

Deaths: 4 deaths

Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 4 deaths

Serious adverse events

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 participants at risk Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 participants at risk Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 participants at risk Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 participants at risk Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 participants at risk Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Arthritis infective	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Immune system disorders Cytokine release syndrome	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Death	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Osteomyelitis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Pneumonia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	37.5% 3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Pneumonia bacterial	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Pyrexia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Sepsis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.

Other adverse events

Measure	Phase 1b, Part 1: TAK-981 60 mg BIW + Mezagitamab 600 mg n=3 participants at risk Participants received TAK-981 60 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg BIW + Mezagitamab 600 mg n=3 participants at risk Participants received TAK-981 90 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 90 mg QW + Mezagitamab 600 mg n=10 participants at risk Participants received TAK-981 90 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg BIW + Mezagitamab 600 mg n=3 participants at risk Participants received TAK-981 120 mg, infusion, intravenously, twice weekly on Days 1, 4, 8, 11 and 15, and mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15 and 22 during Cycles 1 and 2, then once every 2 weeks during Cycles 3 through 6, further once every 4 weeks, until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.	Phase 1b, Part 1: TAK-981 120 mg QW + Mezagitamab 600 mg n=8 participants at risk Participants received TAK-981 120 mg, infusion, intravenously, in combination with mezagitamab 600 mg, injection, subcutaneously, once weekly on Days 1, 8, 15, 22 during Cycles 1 and 2, then every 2 weeks during Cycles 3 through 6, further once every 4 weeks until disease progression or unacceptable toxicity, or until any other discontinuation criterion is met, whichever occurs first. Each Cycle length was 28 days.
Eye disorders Vision blurred	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Lipase increased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Psychiatric disorders Depression	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	100.0% 3/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	62.5% 5/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Dizziness	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Eye disorders Dry eye	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Dysgeusia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Gastrointestinal disorders Dyspepsia	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Gastrointestinal disorders Dysphagia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Ear and labyrinth disorders Ear disorder	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Epidural lipomatosis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Fatigue	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	40.0% 4/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	50.0% 4/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Flank pain	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Gastrointestinal disorders Flatulence	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Fungal skin infection	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Gait disturbance	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Headache	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Herpes zoster	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Hiccups	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	37.5% 3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	37.5% 3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Vascular disorders Hypotension	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Endocrine disorders Hypothyroidism	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Influenza like illness	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Psychiatric disorders Insomnia	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Lethargy	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Lymphocyte count decreased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Vascular disorders Lymphoedema	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Blood and lymphatic system disorders Lymphopenia	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Memory impairment	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Muscle spasms	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	30.0% 3/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Gastrointestinal disorders Nausea	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	37.5% 3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Neutrophil count decreased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Oedema peripheral	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Osteolysis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Pain	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Painful respiration	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Peripheral sensorimotor neuropathy	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Platelet count decreased	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	100.0% 3/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Pneumocystis jirovecii pneumonia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Pneumonia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Pneumonia bacterial	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Pyrexia	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Rash pustular	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations SARS-CoV-2 test positive	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Sialoadenitis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Skin abrasion	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Somnolence	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Spinal cord compression	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Streptococcal infection	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Swelling	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Cardiac disorders Tachycardia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Tooth infection	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Renal and urinary disorders Urinary incontinence	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Urinary tract infection	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Ear and labyrinth disorders Vertigo	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Gastrointestinal disorders Vomiting	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	37.5% 3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Weight decreased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations White blood cell count decreased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Abscess limb	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Alanine aminotransferase increased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	30.0% 3/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	62.5% 5/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Psychiatric disorders Anxiety	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Arthralgia	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Asthenia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Musculoskeletal and connective tissue disorders Back pain	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	20.0% 2/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Blood creatinine increased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Investigations CD4 lymphocytes decreased	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Catheter site pain	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Cellulitis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Ear and labyrinth disorders Cerumen impaction	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
General disorders Chills	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	66.7% 2/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Nervous system disorders Cognitive disorder	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Psychiatric disorders Confusional state	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Gastrointestinal disorders Constipation	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	12.5% 1/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	37.5% 3/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Infections and infestations Cytomegalovirus infection	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	33.3% 1/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	25.0% 2/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.
Vascular disorders Deep vein thrombosis	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	10.0% 1/10 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/3 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.	0.00% 0/8 • From the first dose of study drug through 30 days after the last dose of study drug (up to 13 months) The study was terminated after completion of Phase 1b Part 1, therefore, no participants were enrolled in Phase 1b-Part 2 and Phase 2 of this study. Hence, no safety data for Phase 1b-Part 2 and Phase 2 was collected, analyzed and reported in this AEs section.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: TrialDisclosures@takeda.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place