Trial Outcomes & Findings for DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia (NCT NCT04752163)

NCT ID: NCT04752163

Last Updated: 2025-05-23

Results Overview

The highest dose of DS-1594b treatment that does not cause unacceptable side effects.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

17 participants

Primary outcome timeframe

Day 28

Results posted on

2025-05-23

Participant Flow

Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Participant milestones

Participant milestones
Measure	Phase I (DS-1594b) Cohort 1 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO
Overall Study STARTED	4	4	5	3	1
Overall Study COMPLETED	4	4	5	3	1
Overall Study NOT COMPLETED	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

DS-1594b With or Without Azacitidine, Venetoclax, or Mini-HCVD for the Treatment of Relapsed or Refractory Acute Myeloid Leukemia or Acute Lymphoblastic Leukemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV	Total n=17 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	10 Participants n=42 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	7 Participants n=42 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	—	—	—	5 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	—	—	—	12 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	—	—	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	—	—	1 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	—	—	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	—	—	—	3 Participants n=42 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	—	—	—	13 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	—	—	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	—	—	—	0 Participants n=42 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	5 participants n=5 Participants	3 participants n=4 Participants	1 participants n=21 Participants	—	—	—	17 participants n=42 Participants

PRIMARY outcome

Timeframe: Day 28

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

The highest dose of DS-1594b treatment that does not cause unacceptable side effects.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Maximum Tolerated Dose (MTD) (Phase I)	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	—	—	—

PRIMARY outcome

Timeframe: Day 28

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

This will be selected based upon the cumulative safety, efficacy and PK data at the end of the Phase 1 portion when the maximum tolerated dose is found. This will be One dose level below the RP2D of DS-1594b from Phase 1.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Recommended Phase 2 Dose (RP2D) (Phase I)	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	NA Milligrams The maximum tolerated dose in phase I was not reached. insufficient number of participants with events, study terminated early.	—	—	—

PRIMARY outcome

Timeframe: 3 months

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

AML Participants: (CR) is No circulating blasts, Neutrophils \> 1.0 x 10 \^ 9/L OR Platelet Count \> 100 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods, No extramedullary leukemia. (CRh) is defined No circulating blasts, Neutrophils \>/= 0.5 x 10 \^ 9/L, Platelet Count \>/= 50 x 10 \^ 9/L, Bone marrow aspirate and biopsy \<5% blasts, No Auer rods. ALL Participants: (CR) is No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \> 1.0 x 10 \^ 9/L, platelet count \> 100 x 10 \^ 9/L, No recurrence for 4 weeks. (CRh) No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \>/= 0.5 x 10 \^ 9/L, \>/= 50 x 10 \^ 9/L, No recurrence for 4 weeks.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

ALL Participants: (CR) is No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \> 1.0 x 10 \^ 9/L, platelet count \> 100 x 10 \^ 9/L, No recurrence for 4 weeks. (CRh) No circulating lymphoblast or extramedullary disease, No lymphadenopathy, splenomegaly, skin/gum infiltration/testicular mass/CNS involvement. Trilineage hematopoiesis (TLH) and \<5% blasts, Neutrophil count \>/= 0.5 x 10 \^ 9/L, \>/= 50 x 10 \^ 9/L, No recurrence for 4 weeks.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: 3 months

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Defined as CR + complete remission with incomplete blood count recovery (CRi), morphologic leukemia free survival (MLFS), partial remission (PR), and overall response rate of subjects with R/R AML and R/R ALL treated on single-agent or combinations of DS-1594b.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Composite CR (CRc) Rate	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

AML Participants: Bone marrow \< 5% myeloblasts, no auer rods, no extramedullary leukemia, neutrophil or platelet recovery is not required.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Participants With Morphologic Leukemia-free State (MLFS)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Partial remission (PR), Neutrophil count: \>1.0 x109/L, Platelet count \>100 x109/L, ≥ 50 % reduction in bone marrow blast from pretreatment baseline, but still ≥ 5%.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Participants With a Partial Response (PR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Defined as CR + CRi + MLFS + PR. Complete remission (CR), Peripheral blood counts: No circulating blasts, Neutrophil count: \>1.0 x109/L, Platelet count \>100 x109/L, Bone marrow aspirate and biopsy: \< 5% blasts, No Auer rods, No extramedullary leukemia. CRi is the same as CR except Neutrophil count: \<1.0 x109/L, OR Platelet count: \<100 x109/L. MLFS is Bone marrow \< 5% myeloblasts, No Auer rods, No extramedullary leukemia, Neutrophil or platelet recovery is not required. PR is Neutrophil count: \>1.0 x109/L, Platelet count \>100 x109/L, \>/= 50 % reduction in bone marrow blast from pretreatment baseline, but still \>/= 5%

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Number of Participants With a Response	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: There were zero responses, therefore duration of response was not calculated. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Response date to loss of response or last follow up.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: There were zero responses, therefore time from response to best response was not calculated. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

First response date to best response date.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

TI is defined as the absence of red blood cell and platelet transfusions for a consecutive 56-day period during continued treatment.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Rate of Durable Transfusion Independence (TI)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to the date of failure or death from any cause, approximately 2 years, 7 months

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Time from date of treatment start until the date of failure or death from any cause.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Event-free Survival	1.8 Months Interval 0.5 to 3.3	0.7 Months Interval 0.1 to 1.2	1.2 Months Interval 0.6 to 3.0	2.6 Months Interval 1.9 to 4.6	0.8 Months Interval 0.8 to 0.8	—	—	—

SECONDARY outcome

Timeframe: Up to the date of death or last follow-up, approximately 2 years, 7 months

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Estimated using the Kaplan-Meier method.From the date of the treatment start to the date of death or to the date of last follow-up if patients are alive at the time of data collection

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Overall Survival	4.3 Months Interval 0.5 to 6.7	1.9 Months Interval 0.1 to 4.0	2.3 Months Interval 1.1 to 8.5	6.2 Months Interval 5.5 to 6.9	7.2 Months Interval 7.2 to 7.2	—	—	—

SECONDARY outcome

Timeframe: 4 weeks

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Number of deaths to occur within 4 weeks from start of therapy to 4 weeks into therapy.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Mortality Rate	1 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: 8 weeks

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Number of deaths to occur within 8 weeks from start of therapy to 8 weeks into therapy.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Mortality Rate	1 Participants	2 Participants	2 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Outcome measures

Outcome measures
Measure	Phase I (DS-1594b) Cohort 1 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 Participants Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Number of Subjects Able to Proceed to Hematopoietic Stem Cell Transplantation (HSCT) Without Additional AML Therapy	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—	—

SECONDARY outcome

Timeframe: Up to 2 years

Population: Zero Participants went on to HSCT, therefore the median duration to HSCT was not done. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Calculated time to HSCR for participants who went on to HSCT.

Outcome measures

Outcome data not reported

Adverse Events

Phase I (DS-1594b) Cohort 1

Serious events: 4 serious events

Other events: 4 other events

Deaths: 2 deaths

Phase I (DS-1594b) Cohort 2

Serious events: 4 serious events

Other events: 4 other events

Deaths: 3 deaths

Phase I (DS-1594b) Cohort 3

Serious events: 5 serious events

Other events: 5 other events

Deaths: 2 deaths

Phase I (DS-1594b) Cohort 4

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase I (DS-1594b) Cohort 5

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Phase 2 Cohort A and B (DS-1594b)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phase 2 Cohort D (DS-1594b, Mini-HCVD)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I (DS-1594b) Cohort 1 n=4 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Renal and urinary disorders Acute kidney injury	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Immune system disorders Allergic reaction	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Atrial fibrillation	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Bacteremia	75.0% 3/4 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Cardiac disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Cytomegalovirus infection reactivation	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Disease progression	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Enterocolitis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Eye disorders Eye disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Eye infection	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Fatigue	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Fever	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders General disorders and administration site conditions - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Infective myositis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Intracranial hemorrhage	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Joint infection	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Leukocytosis	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Lung infection	75.0% 3/4 • Number of events 6 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Ear and labyrinth disorders Middle ear inflammation	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Nausea	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Nervous system disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Retinoic acid syndrome	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Retroperitoneal hemorrhage	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Sepsis	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Sinus bradycardia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Sinus tachycardia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Sinusitis	25.0% 1/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Skin infection	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Soft tissue infection	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Syncope	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Tumor lysis syndrome	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Vomiting	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Wound infection	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Other adverse events

Other adverse events
Measure	Phase I (DS-1594b) Cohort 1 n=4 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 70 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 2 n=4 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg twice daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 3 n=5 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 20 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 4 n=3 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 50 mg daily. DS-1594b: Given DS-1594b PO	Phase I (DS-1594b) Cohort 5 n=1 participants at risk Patients receive DS-1594b PO BID on days 1-28 in the absence of disease progression or unacceptable toxicity. 100 mg daily. DS-1594b: Given DS-1594b PO	Phase 2 Cohort A and B (DS-1594b) Patients with MLLr or NPM1m receive DS-1594b PO BID on days 1-28. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO	Phase 2 Cohort C (DS-1594b, Venetoclax, Azacitidine) Patients receive DS-1594b PO BID on days 1-28, venetoclax PO QD on days 1-28, and azacitidine IV or SC on days 1-7. Cycles repeat every 28 days for up to 2 years in the absence of disease progression or unacceptable toxicity. DS-1594b: Given DS-1594b PO Azacitidine: Given IV or SC Venetoclax: Given PO	Phase 2 Cohort D (DS-1594b, Mini-HCVD) Patients receive DS-1594b PO BID on days 1-28. For additional information, see trial description. DS-1594b: Given DS-1594b PO Cyclophosphamide: Given IV Cytarabine: Given IT Dexamethasone: Given PO or IV Filgrastim: Given SC Leucovorin: Given IV or PO Mesna: Given IV Methotrexate: Given IT Prednisone: Given PO Rituximab: Given IV Vincristine: Given IV
Gastrointestinal disorders Fecal incontinence	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Fever	75.0% 3/4 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Fibrinogen decreased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Abdominal distension	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Acidosis	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Renal and urinary disorders Acute kidney injury	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Psychiatric disorders Agitation	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Alanine aminotransferase increased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 3/3 • Number of events 6 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Alkaline phosphatase increased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Allergic rhinitis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Anemia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Anorexia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Psychiatric disorders Anxiety	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Musculoskeletal and connective tissue disorders Arthritis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Aspartate aminotransferase increased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Blood and lymphatic system disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	75.0% 3/4 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	60.0% 3/5 • Number of events 5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Blood bilirubin increased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Blood lactate dehydrogenase increased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Eye disorders Blurred vision	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Injury, poisoning and procedural complications Bruising	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations BUN increased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Cardiac troponin I increased	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Chills	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Colitis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Psychiatric disorders Confusion	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Constipation	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Cough	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Creatinine increased	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Renal and urinary disorders Cystitis noninfective	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Psychiatric disorders Depression	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Diarrhea	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 6 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Dizziness	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Dysarthria	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Dyspnea	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Renal and urinary disorders Dysuria	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Edema	50.0% 2/4 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Electrocardiogram QT corrected interval prolonged	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Epistaxis	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Skin and subcutaneous tissue disorders Erythema multiforme	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Eye disorders Eye disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Injury, poisoning and procedural complications Fall	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Fatigue	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Gait disturbance	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Gastroesophageal reflux disease	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Gastrointestinal disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Musculoskeletal and connective tissue disorders Generalized muscle weakness	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Vascular disorders Hematoma	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Renal and urinary disorders Hematuria	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Hemorrhoids	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Vascular disorders Hot flashes	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypercalcemia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hyperglycemia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hyperkalemia	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypermagnesemia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypernatremia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hyperphosphatemia	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 3/3 • Number of events 7 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Vascular disorders Hypertension	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypertriglyceridemia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hyperuricemia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypoalbuminemia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypocalcemia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypokalemia	25.0% 1/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 6 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypomagnesemia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hyponatremia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Metabolism and nutrition disorders Hypophosphatemia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Vascular disorders Hypotension	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 3/3 • Number of events 4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Hypoxia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Infections and infestations - Other, specify	50.0% 2/4 • Number of events 4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	40.0% 2/5 • Number of events 4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations INR increased	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Psychiatric disorders Insomnia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Investigations - Other, specify	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Blood and lymphatic system disorders Leukocytosis	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Malaise	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Mucositis oral	25.0% 1/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Musculoskeletal and connective tissue disorders Muscle cramp	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Myocarditis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Nasal congestion	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Nausea	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
General disorders Pain	75.0% 3/4 • Number of events 5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 4/4 • Number of events 8 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 5/5 • Number of events 12 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 3/3 • Number of events 8 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 8 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysesthesia syndrome	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Palpitations	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Pancreatitis	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Postnasal drip	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Skin and subcutaneous tissue disorders Rash	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 7 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Reproductive system and breast disorders Reproductive system and breast disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Respiratory failure	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders - Other, specify	75.0% 3/4 • Number of events 3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Retinoic acid syndrome	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Respiratory, thoracic and mediastinal disorders Rhinorrhea	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Seizure	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Sepsis	25.0% 1/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Sinus bradycardia	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Cardiac disorders Sinus tachycardia	50.0% 2/4 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	66.7% 2/3 • Number of events 2 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders - Other, specify	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Syncope	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 1/1 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Infections and infestations Thrush	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Nervous system disorders Tremor	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Renal and urinary disorders Urinary incontinence	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Renal and urinary disorders Urine discoloration	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Eye disorders Vitreous hemorrhage	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	25.0% 1/4 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/3 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Gastrointestinal disorders Vomiting	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/5 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	100.0% 3/3 • Number of events 4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.
Investigations Weight loss	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/4 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	20.0% 1/5 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	33.3% 1/3 • Number of events 1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	0.00% 0/1 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.	— 0/0 • Up to the date of failure or death from any cause, approximately 3 years 7 months. Participant were only enrolled in the phase 1 portion of this study. The study was terminated early and did not move on to Phase 2.

Additional Information

Naval Daver MD./Professor

The University of MD Anderson Cancer Center

Phone: 713-794-4392

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place