Trial Outcomes & Findings for INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma (NCT NCT03837509)

Last Updated: 2025-11-04

Results Overview

A TEAE was defined as an adverse event (AE) that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

15 participants

Primary outcome timeframe

up to 454 days

Results posted on

2025-11-04

Participant Flow

Participant milestones

Participant milestones
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 100 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Phase 2 STARTED	0	0	2	1	2
Phase 1 STARTED	6	4	0	0	0
Phase 1 COMPLETED	1	2	0	0	0
Phase 1 NOT COMPLETED	5	2	0	0	0
Phase 2 Disease Progression in Part 1	0	0	0	1	2
Phase 2 COMPLETED	0	0	2	0	1
Phase 2 NOT COMPLETED	0	0	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 100 mg BID + Daratumumab In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Phase 1 Death	5	2	0	0	0
Phase 2 Death	0	0	0	1	1

Baseline Characteristics

INCB001158 Combined With Subcutaneous (SC) Daratumumab, Compared to Daratumumab SC, in Relapsed or Refractory Multiple Myeloma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=6 Participants In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=4 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 100 mg BID + Daratumumab n=2 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab n=1 Participants In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 Participants In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Total n=15 Participants Total of all reporting groups
Age, Continuous	65.0 years STANDARD_DEVIATION 11.70 • n=15 Participants	68.0 years STANDARD_DEVIATION 9.83 • n=161 Participants	67.0 years STANDARD_DEVIATION 12.73 • n=100 Participants	NA years STANDARD_DEVIATION NA • n=3 Participants	71.5 years STANDARD_DEVIATION 19.09 • n=8 Participants	67.1 years STANDARD_DEVIATION 10.59 • n=7 Participants
Sex: Female, Male Female	2 Participants n=15 Participants	2 Participants n=161 Participants	1 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants
Sex: Female, Male Male	4 Participants n=15 Participants	2 Participants n=161 Participants	1 Participants n=100 Participants	NA Participants n=3 Participants	2 Participants n=8 Participants	NA Participants n=7 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	1 Participants n=8 Participants	NA Participants n=7 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=15 Participants	4 Participants n=161 Participants	2 Participants n=100 Participants	NA Participants n=3 Participants	1 Participants n=8 Participants	NA Participants n=7 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants
Race (NIH/OMB) Black or African American	1 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants
Race (NIH/OMB) White	5 Participants n=15 Participants	4 Participants n=161 Participants	2 Participants n=100 Participants	NA Participants n=3 Participants	2 Participants n=8 Participants	NA Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=15 Participants	0 Participants n=161 Participants	0 Participants n=100 Participants	NA Participants n=3 Participants	0 Participants n=8 Participants	NA Participants n=7 Participants

PRIMARY outcome

Timeframe: up to 454 days

Population: Full Analysis Population: all participants enrolled in the study who received at least 1 dose of study treatment (INCB001158 or daratumumab subcutaneous \[SC\]). Participants were to be analyzed according to the treatment they were assigned to.

A TEAE was defined as an adverse event (AE) that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=6 Participants In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=4 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Phase 1: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)	6 Participants	4 Participants	—	—	—

PRIMARY outcome

Timeframe: up to Day 386

Population: Full Analysis Population

CR: negative immunofixation on serum/urine, disappearance of soft tissue plasmacytomas, \<5% bone marrow plasma cells (PCs). VGPR: serum/urine M-component detectable by immunofixation but not on electrophoresis, or ≥90% reduction in serum M-protein (SMP) plus urine M-protein (UMP) \<100 milligrams (mg)/24 hours. PR: ≥50% reduction of SMP and reduction in 24-hour UMP by ≥90% or to \<200 mg/24 hours. SMP and UMP not measurable: decrease of ≥50% in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria. SMP and UMP not measurable, and serum free light assay is not measurable: ≥50% reduction in bone marrow PCs is required in place of M-protein, if Baseline bone marrow PC percentage was ≥30%. If present at Baseline, a ≥50% reduction in the size of soft tissue plasmacytomas is required.

Outcome measures

Outcome measures
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=2 Participants In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=1 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 Participants In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Phase 2: Overall Response Rate (ORR): Number of Participants With a Documented Response of Complete Response (CR), Very Good Partial Response (VGPR), or PR, as Per International Myeloma Working Group (IMWG) Criteria	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: up to Day 395

Population: Full Analysis Population

Outcome measures

Outcome measures
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=6 Participants In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=4 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Phase 1: ORR: Number of Participants With a Documented Response of CR, VGPR, or PR, as Per IMWG Criteria	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: up to 420 days

Population: Full Analysis Population

A TEAE was defined as an AE that was reported for the first time or the worsening of a pre-existing event after the first dose of study treatment.

Outcome measures

Outcome measures
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=2 Participants In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=1 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 Participants In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Phase 2: Number of Participants With Any TEAE	1 Participants	1 Participants	1 Participants	—	—

SECONDARY outcome

Timeframe: up to Day 395

Population: No participants had a response of PR or better; thus, analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 386

Population: No participants had a response of PR or better; thus, analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 395

Population: No participants had a response of PR or better; thus, analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to Day 386

Population: No participants had a response of PR or better; thus, analysis was not conducted.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to approximately 2 years

Population: Full Analysis Population. As a result of an early-termination decision following a recruitment challenge (no safety-related concerns), a formal analysis was not performed due to an insufficient number of participants enrolled in Phase 2. PFS was calculated for individual participants, but data were not formally analyzed.

Progressive disease: increase of 25% from the lowest response value in any one of the following: (a) serum M-component (absolute increase must be ≥0.5 grams per deciliter \[g/dL\]); (b) urine M-component (absolute increase must be ≥200 mg/24 hours); (c) only in participants without measurable serum and urine M-protein levels: the difference between involved and uninvolved FLC levels (absolute increase must be \> 10 mg/dL); (d) only in participants without measurable serum and urine M-protein levels and without measurable disease by FLC levels, bone marrow plasma cell (PC) percentage (absolute percentage must be ≥10%); (d) bone marrow PC 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 hypercalcemia (corrected serum calcium \> 11.5 mg/dL) that can be attributed solely to the PC proliferative disorder.

Outcome measures

Outcome measures
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=6 Participants In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=4 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 Participants In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab n=1 Participants In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 Participants In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Progression-free Survival (PFS), Defined as the Duration From the Date of the First Dose of Study Drug Until Either Progressive Disease, as Per IMWG Criteria, or Death, Whichever Occurred First Minimum value, uncensored	8 days	26 days	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Progression-free Survival (PFS), Defined as the Duration From the Date of the First Dose of Study Drug Until Either Progressive Disease, as Per IMWG Criteria, or Death, Whichever Occurred First Maximum value, uncensored	337 days	169 days	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.

SECONDARY outcome

Timeframe: up to approximately 2 years

Population: The MRD assay required an analysis to be performed at Baseline and another analysis to be performed at the time of suspected complete response. At the time enrollment was halted, no participants had a complete response; thus, MRD analysis was not performed.

Bone marrow aspirate was to be collected for MRD analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to approximately 2 years

Bone marrow aspirate was to be collected for MRD analysis.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 923 days (approximately 2.5 years)

Population: Full Analysis Population. As a result of an early-termination decision following a recruitment challenge (no safety-related concerns), a formal analysis was not performed due to an insufficient number of participants enrolled in Phase 2. Overall survival was calculated for individual participants, but data were not formally analyzed.

Overall survival was defined as the time from the first dose of study drug to death from any cause until study completion.

Outcome measures

Outcome measures
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=6 Participants In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=4 Participants In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=1 Participants In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 Participants In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=1 Participants In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.
Overall Survival Minimum value, uncensored	113 days	127 days	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.
Overall Survival Maximum value, uncensored	766 days	604 days	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.	NA days Minimum and maximum data values cannot be reported; doing so for the small sample size could lead to the re-identification of participants.

Adverse Events

Phase 1: INCB001158 75 mg BID + Daratumumab

Serious events: 3 serious events

Other events: 6 other events

Deaths: 5 deaths

Phase 1: INCB001158 100 mg BID + Daratumumab

Serious events: 1 serious events

Other events: 4 other events

Deaths: 2 deaths

Phase 2: INCB001158 100 mg BID + Daratumumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Total

Serious events: 5 serious events

Other events: 13 other events

Deaths: 9 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=6 participants at risk In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=4 participants at risk In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 100 mg BID + Daratumumab n=2 participants at risk In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab n=1 participants at risk In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 participants at risk In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Total n=15 participants at risk Total
Cardiac disorders Atrial fibrillation	16.7% 1/6 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Condition aggravated	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Gastrointestinal disorders Constipation	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Psychiatric disorders Delirium	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Fatigue	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Pain	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Infections and infestations Pneumonia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Metabolism and nutrition disorders Type 2 diabetes mellitus	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.

Other adverse events

Other adverse events
Measure	Phase 1: INCB001158 75 mg BID + Daratumumab n=6 participants at risk In Phase 1, participants received oral INCB001158 75 milligrams (mg) twice daily (BID) in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 1: INCB001158 100 mg BID + Daratumumab n=4 participants at risk In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: INCB001158 100 mg BID + Daratumumab n=2 participants at risk In Phase 1, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment continued until disease progression, unacceptable toxicity, or discontinuation from study treatment for any other reason.	Phase 2: Daratumumab Monotherapy; Cross Over to INCB001158 + Daratumumab n=1 participants at risk In Part 1 of Phase 2, participants received daratumumb 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2 (28-day cycles), once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. At the time of confirmed disease progression, participants crossed over to Part 2 of Phase 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Phase 2: INCB001158 Monotherapy; Cross Over to INCB001158 + Daratumumab n=2 participants at risk In Part 1 of Phase 2, participants received oral INCB001158 100 mg BID in 28-day cycles starting at Cycle 1. At the time of confirmed disease progression, participants crossed over to Part 2 of Part 2 to receive oral INCB001158 100 mg BID starting at Cycle 1, and 1800 mg subcutaneous daratumumab, administered once weekly for Cycles 1 and 2, once every 2 weeks for Cycles 3 to 6, and once every 4 weeks thereafter. Treatment in Phase 2 continued for as long as participants were receiving clinical benefit and did not met any criteria for study withdrawal.	Total n=15 participants at risk Total
Gastrointestinal disorders Abdominal pain	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Investigations Alanine aminotransferase increased	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Investigations Aspartate aminotransferase increased	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Asthenia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	26.7% 4/15 • Number of events 4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Musculoskeletal and connective tissue disorders Bone pain	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Cardiac disorders Cardiac failure	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Cardiac disorders Cardiovascular insufficiency	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Injury, poisoning and procedural complications Clavicle fracture	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Gastrointestinal disorders Constipation	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Psychiatric disorders Depression	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • Number of events 3 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	20.0% 3/15 • Number of events 3 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Discomfort	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Nervous system disorders Dysaesthesia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Gastrointestinal disorders Dyspepsia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Respiratory, thoracic and mediastinal disorders Dyspnoea	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Nervous system disorders Dysstasia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Fatigue	50.0% 3/6 • Number of events 3 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	26.7% 4/15 • Number of events 4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Vascular disorders Flushing	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Nervous system disorders Headache	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Metabolism and nutrition disorders Hyperglycaemia	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Vascular disorders Hypertension	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Metabolism and nutrition disorders Hypophosphataemia	16.7% 1/6 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Skin and subcutaneous tissue disorders Ingrowing nail	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Injection site bruising	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Psychiatric disorders Listless	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Respiratory, thoracic and mediastinal disorders Lung infiltration	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Musculoskeletal and connective tissue disorders Muscle spasms	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Musculoskeletal and connective tissue disorders Myalgia	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Respiratory, thoracic and mediastinal disorders Nasal congestion	33.3% 2/6 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Infections and infestations Nasopharyngitis	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Gastrointestinal disorders Nausea	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 2/4 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Nervous system disorders Neuropathy peripheral	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Oedema peripheral	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	20.0% 3/15 • Number of events 3 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Infections and infestations Oral candidiasis	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Metabolism and nutrition disorders Oroticaciduria	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Nervous system disorders Peripheral sensory neuropathy	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Respiratory, thoracic and mediastinal disorders Productive cough	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
General disorders Pyrexia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	13.3% 2/15 • Number of events 3 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Infections and infestations Rhinovirus infection	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	100.0% 1/1 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Injury, poisoning and procedural complications Rib fracture	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Injury, poisoning and procedural complications Skin laceration	16.7% 1/6 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/6 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	25.0% 1/4 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	50.0% 1/2 • Number of events 1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	20.0% 3/15 • Number of events 3 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.
Infections and infestations Tooth infection	16.7% 1/6 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/4 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/1 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	0.00% 0/2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.	6.7% 1/15 • Number of events 2 • Adverse events were assessed for up to 454 days; All-cause Mortality was assessed for up to 923 days (approximately 2.5 years). Treatment-emergent adverse events (TEAEs), defined as adverse events that were reported for the first time or the worsening of pre-existing events after the first dose of study treatment, have been reported.

Additional Information

Study Director

Incyte Corporation

Phone: 1-855-463-3463

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER