Trial Outcomes & Findings for Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML) (NCT NCT03303339)

Last Updated: 2023-02-27

Results Overview

Dose-limiting toxicities were defined as events related to onvansertib that were considered an adverse reaction or suspected adverse reaction during the first cycle of therapy and that fulfilled one of the following: Hematologic (persistent pancytopenia resistant to current standards of care that continues for ≥42 days and is not related to leukemic infiltration or another cause unrelated to study therapy) or Non-Hematologic (any Grade 3 abnormalities that persist \>7 days without decreasing in severity despite standards of care, are clinically significant, or that are Grade 4 and symptomatic).

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

72 participants

Primary outcome timeframe

Up to Day 28 of Cycle 1

Results posted on

2023-02-27

Participant Flow

72 participants were enrolled across 8 sites in the United States.

Participant milestones

Participant milestones
Measure	Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle.
Overall Study STARTED	3	3	3	3	5	4	3	3	4	3	6	32
Overall Study COMPLETED	0	1	1	2	0	1	0	1	0	0	1	4
Overall Study NOT COMPLETED	3	2	2	1	5	3	3	2	4	3	5	28

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle.
Overall Study Death	2	2	2	1	4	2	2	2	3	3	4	24
Overall Study Study Terminated by Sponsor	0	0	0	0	0	0	0	0	1	0	1	1
Overall Study Withdrawal by Subject	1	0	0	0	0	1	1	0	0	0	0	2
Overall Study Physician Decision	0	0	0	0	1	0	0	0	0	0	0	0
Overall Study Safety/Non-compliance	0	0	0	0	0	0	0	0	0	0	0	1

Baseline Characteristics

Onvansertib in Combination With Either Low-dose Cytarabine or Decitabine in Adult Patients With Acute Myeloid Leukemia (AML)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to Day 10 of each cycle, in order to determine the RP2D of onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of onvansertib	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=32 Participants Participants were administered onvansertib at the RP2D on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle.	Total n=72 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	2 Participants n=64 Participants	2 Participants n=17 Participants	4 Participants n=21 Participants	18 Participants n=22 Participants
Age, Categorical >=65 years	3 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	1 Participants n=64 Participants	4 Participants n=17 Participants	28 Participants n=21 Participants	54 Participants n=22 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants	1 Participants n=10 Participants	1 Participants n=115 Participants	1 Participants n=6 Participants	1 Participants n=6 Participants	1 Participants n=64 Participants	3 Participants n=17 Participants	13 Participants n=21 Participants	25 Participants n=22 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=10 Participants	2 Participants n=115 Participants	2 Participants n=6 Participants	3 Participants n=6 Participants	2 Participants n=64 Participants	3 Participants n=17 Participants	19 Participants n=21 Participants	47 Participants n=22 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants	5 Participants n=22 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	4 Participants n=6 Participants	1 Participants n=64 Participants	6 Participants n=17 Participants	30 Participants n=21 Participants	63 Participants n=22 Participants
Ethnicity (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=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	2 Participants n=64 Participants	0 Participants n=17 Participants	1 Participants n=21 Participants	4 Participants n=22 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	1 Participants n=17 Participants	0 Participants n=21 Participants	1 Participants n=22 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	1 Participants n=64 Participants	0 Participants n=17 Participants	3 Participants n=21 Participants	6 Participants n=22 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	1 Participants n=6 Participants	4 Participants n=6 Participants	2 Participants n=64 Participants	5 Participants n=17 Participants	29 Participants n=21 Participants	62 Participants n=22 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=10 Participants	0 Participants n=115 Participants	0 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	0 Participants n=22 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=10 Participants	0 Participants n=115 Participants	1 Participants n=6 Participants	0 Participants n=6 Participants	0 Participants n=64 Participants	0 Participants n=17 Participants	0 Participants n=21 Participants	3 Participants n=22 Participants

PRIMARY outcome

Timeframe: Up to Day 28 of Cycle 1

Population: The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=3 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Number of Participants Who Experienced Dose Limiting Toxicities (DLT)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	—	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Baseline and end of study (approximately up to up to 27 months)

Population: Per SAP It was pre-planned to report this data by treatment type instead of by dose.

ECOG performance status was determined using 6-point scale from 0-5, with 0 meaning a participant was fully active/able to carry on all pre-disease activities without restriction and 5 meaning the participant was deceased.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=32 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=17 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=23 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Number of Participants With Change From Baseline in Eastern Co-operative Oncology Group (ECOG) Performance Status	—	—	—	—	—	—	—	—	22 Participants	—	11 Participants	14 Participants

PRIMARY outcome

Timeframe: Up to 27 months

Population: Only participants in Phase 2 were included in this analysis.

Complete Response also includes Complete Response with Incomplete Blood Count Recovery (CRi). Complete response is defined by the following criteria: Morphologic leukemia-free state plus: * Subject is independent of transfusions * Absolute neutrophil count of \>1000/mm3 * Platelets of ≥100,000/mm3 Complete response with incomplete blood count recovery meets all criteria for CR except for either neutropenia (ANC \<1000/mm3) or thrombocytopenia (\<100,000/mm3) but must include transfusion independence.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=32 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Phase 2: Number of Participants Who Achieved a Complete Response (CR)	—	—	—	—	—	—	—	—	—	—	3 Participants	—

PRIMARY outcome

Timeframe: Baseline up to 30 days after last dose of study drug (up to 27 months)

Population: The safety analysis set was comprised of all subjects who received at least one dose of onvansertib.

Any clinically significant change in electrocardiogram (ECG), physical examination findings, body weight, vital signs, and laboratory parameters were recorded as Adverse Events.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=32 Participants Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=3 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Number of Participants With Adverse Events (AEs) Any Adverse Events	5 Participants	4 Participants	3 Participants	3 Participants	4 Participants	3 Participants	6 Participants	32 Participants	3 Participants	3 Participants	3 Participants	3 Participants
Number of Participants With Adverse Events (AEs) Any Serious Adverse Events	3 Participants	2 Participants	3 Participants	3 Participants	4 Participants	2 Participants	5 Participants	27 Participants	1 Participants	2 Participants	2 Participants	3 Participants
Number of Participants With Adverse Events (AEs) Any Treatment-Related Serious Adverse Events	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	1 Participants	3 Participants	5 Participants	0 Participants	1 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 27 months

Population: Only participants in Phase 2 were included in this analysis.

Defined as bone marrow (BM) \<5% blasts in an aspirate with spicules and no blasts with Auer rods or persistence of extramedullary disease.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=32 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Phase 2: Number of Participants Who Achieved a Morphologic Leukemia-free (MLF) State	—	—	—	—	—	—	—	—	—	—	1 Participants	—

SECONDARY outcome

Timeframe: Up to 27 months

Population: Only participants included in Phase 2 were used in this analysis.

PR criteria includes all of the hematologic values for a CR but with a decrease of at least 50% in the percentage of blasts to 5% to 25% in the bone marrow aspirate and a normalization of blood counts.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=32 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Phase 2: Number of Participants With Partial Response (PR)	—	—	—	—	—	—	—	—	—	—	0 Participants	—

SECONDARY outcome

Timeframe: Up to 27 months

Population: Only participants in Phase 2 were included in this analysis.

Duration of Response (DOR) is the time (in months) from the first response of CR, CRi or PR until recurrence of or progression of disease (or death). MLF State is also included as a response when calculating DOR. Responding subjects without death or progression will be censored at the date of their last evaluable disease assessment.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=3 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Phase 2: Duration of Response (DOR)	—	—	—	—	—	—	—	—	—	—	5.2 months Interval 0.0 to 9.1	—

SECONDARY outcome

Timeframe: 12 Months

Population: Only participants in Phase 2 were included in this analysis.

EFS is defined as the time from enrollment until disease progression or death from any cause and reported as the proportion of participants event free at 12 months.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=32 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Phase 2: Event-free Survival (EFS)	—	—	—	—	—	—	—	—	—	—	0.1 Proportion of Participants Interval 0.0 to 0.2	—

SECONDARY outcome

Timeframe: 12 Months

Population: Only participants included in Phase 2 were included in this analysis.

OS is defined as the time from enrollment until death from any cause and reported as the proportion of participants alive at 12 months.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=32 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Phase 2: Overall Survival (OS)	—	—	—	—	—	—	—	—	—	—	0.2 Proportion of Participants Interval 0.1 to 0.4	—

SECONDARY outcome

Timeframe: Cycle 1: Days 1 and 5

Population: The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=31 Participants Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=3 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib Cycle 1 Day 5	857.29 ng/mL Geometric Coefficient of Variation 38.54	146.10 ng/mL Geometric Coefficient of Variation 56.75	197.67 ng/mL Geometric Coefficient of Variation 85.14	398.38 ng/mL Geometric Coefficient of Variation 32.95	496.24 ng/mL Geometric Coefficient of Variation 52.72	955.59 ng/mL Geometric Coefficient of Variation 54.78	1137.16 ng/mL Geometric Coefficient of Variation 61.56	861.86 ng/mL Geometric Coefficient of Variation 46.68	298.63 ng/mL Geometric Coefficient of Variation 66.58	339.52 ng/mL Geometric Coefficient of Variation 31.25	139.22 ng/mL Geometric Coefficient of Variation 55.12	103.27 ng/mL Geometric Coefficient of Variation 43.01
Pharmacokinetic Parameter: Maximum Observed Plasma Concentration (Cmax) for Onvansertib Cycle 1 Day 1	626.18 ng/mL Geometric Coefficient of Variation 61.37	80.15 ng/mL Geometric Coefficient of Variation 21.33	129.18 ng/mL Geometric Coefficient of Variation 93.78	309.86 ng/mL Geometric Coefficient of Variation 72.47	410.42 ng/mL Geometric Coefficient of Variation 26.38	724.76 ng/mL Geometric Coefficient of Variation 57.33	737.21 ng/mL Geometric Coefficient of Variation 43.06	515.63 ng/mL Geometric Coefficient of Variation 43.47	251.16 ng/mL Geometric Coefficient of Variation 85.37	256.11 ng/mL Geometric Coefficient of Variation 24.96	92.57 ng/mL Geometric Coefficient of Variation 5.66	69.56 ng/mL Geometric Coefficient of Variation 28.73

SECONDARY outcome

Timeframe: Cycle 1: Days 1 and 5

Population: The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=29 Participants Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=3 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib Cycle 1 Day 1	2.071 Hours Geometric Coefficient of Variation 39.570	3.102 Hours Geometric Coefficient of Variation 31.792	2.365 Hours Geometric Coefficient of Variation 78.396	1.288 Hours Geometric Coefficient of Variation 41.249	1.373 Hours Geometric Coefficient of Variation 49.676	2.893 Hours Geometric Coefficient of Variation 135.893	2.435 Hours Geometric Coefficient of Variation 53.682	2.725 Hours Geometric Coefficient of Variation 69.661	2.301 Hours Geometric Coefficient of Variation 84.217	1.384 Hours Geometric Coefficient of Variation 103.829	1.961 Hours Geometric Coefficient of Variation 81.664	2.548 Hours Geometric Coefficient of Variation 96.282
Pharmacokinetic Parameter: Time to Reach the Maximum Observed Plasma Concentration (Tmax) for Onvansertib Cycle 1 Day 5	2.148 Hours Geometric Coefficient of Variation 55.159	2.438 Hours Geometric Coefficient of Variation 24.524	1.583 Hours Geometric Coefficient of Variation 96.305	3.145 Hours Geometric Coefficient of Variation 33.877	3.161 Hours Geometric Coefficient of Variation 41.350	3.161 Hours Geometric Coefficient of Variation 41.350	3.189 Hours Geometric Coefficient of Variation 29.775	2.665 Hours Geometric Coefficient of Variation 51.333	2.267 Hours Geometric Coefficient of Variation 82.486	1.474 Hours Geometric Coefficient of Variation 67.999	1.844 Hours Geometric Coefficient of Variation 62.646	2.892 Hours Geometric Coefficient of Variation 37.244

SECONDARY outcome

Timeframe: Cycle 1: Days 1 and 5

Population: The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=32 Participants Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=3 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib Cycle 1 Day 1	5386.69 h*ng/mL Geometric Coefficient of Variation 59.16	1099.43 h*ng/mL Geometric Coefficient of Variation 29.81	2789.81 h*ng/mL Geometric Coefficient of Variation 25.30	3257.57 h*ng/mL Geometric Coefficient of Variation 53.53	4084.18 h*ng/mL Geometric Coefficient of Variation 27.94	9599.19 h*ng/mL Geometric Coefficient of Variation 25.01	9087.77 h*ng/mL Geometric Coefficient of Variation 57.43	6280.28 h*ng/mL Geometric Coefficient of Variation 46.85	2534.22 h*ng/mL Geometric Coefficient of Variation 31.05	2761.11 h*ng/mL Geometric Coefficient of Variation 36.97	1197.93 h*ng/mL Geometric Coefficient of Variation 23.42	772.68 h*ng/mL Geometric Coefficient of Variation 26.21
Pharmacokinetic Parameter: Area Under the Curve Over the First 24 Hours AUC(0-24) for Onvansertib Cycle 1 Day 5	19470.17 h*ng/mL Geometric Coefficient of Variation 17.10	1868.69 h*ng/mL Geometric Coefficient of Variation 70.99	3626.44 h*ng/mL Geometric Coefficient of Variation 5.33	5343.01 h*ng/mL Geometric Coefficient of Variation 2.11	7415.04 h*ng/mL Geometric Coefficient of Variation 64.35	19470.17 h*ng/mL Geometric Coefficient of Variation 17.10	12981.17 h*ng/mL Geometric Coefficient of Variation 56.18	11767.29 h*ng/mL Geometric Coefficient of Variation 39.78	5343.01 h*ng/mL Geometric Coefficient of Variation 2.11	7415.04 h*ng/mL Geometric Coefficient of Variation 64.35	1868.69 h*ng/mL Geometric Coefficient of Variation 70.99	3626.44 h*ng/mL Geometric Coefficient of Variation 5.33

SECONDARY outcome

Timeframe: Cycle 1: Days 1 and 5

Population: The PK analysis set consisted of all subjects in the safety analysis set who received onvansertib and had adequate plasma onvansertib concentration data as determined by the PK scientist.

Outcome measures

Outcome measures
Measure	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=2 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=2 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=2 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 5 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=22 Participants Participants were administered onvansertib on Day 1 through Day 5 every 21 to 28 days, in combination with decitabine, administered consistently as 20 mg/m\^2 over 1 hour on Day 1 through Day 5 every 28 days.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=2 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.	Phase 2: Onvansertib + Decitabine n=2 Participants Onvansertib recommended phase 2 dose, orally Day 1 through Day 5 every 28 days (1 cycle) and decitabine, administered consistently as 20 mg/m\^2 intravenously over 1 hour on Day 1 through Day 5 every 28 days (1 cycle), with treatment modifications or delays based on return of hematopoietic function to baseline or Grade ≤1 toxicity for optimal subject management. Onvansertib: Onvansertib orally Decitabine: intravenously	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=2 Participants Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the RP2D of Onvansertib.
Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib Cycle 1 Day 1	7.309 Hours Geometric Coefficient of Variation 99.539	16.960 Hours Geometric Coefficient of Variation 54.430	13.795 Hours Geometric Coefficient of Variation 28.866	9.394 Hours Geometric Coefficient of Variation 20.598	11.389 Hours Geometric Coefficient of Variation 39.530	12.917 Hours Geometric Coefficient of Variation 41.715	12.633 Hours Geometric Coefficient of Variation 50.655	11.904 Hours Geometric Coefficient of Variation 29.602	12.197 Hours Geometric Coefficient of Variation 71.258	11.747 Hours Geometric Coefficient of Variation 63.901	11.294 Hours Geometric Coefficient of Variation 11.098	7.993 Hours Geometric Coefficient of Variation NA Not calculable due to only 1 participant being analyzed.
Pharmacokinetic Parameter: Plasma Terminal Elimination Half-life (t1/2) for Onvansertib Cycle 1 Day 5	14.484 Hours Geometric Coefficient of Variation 32.002	13.282 Hours Geometric Coefficient of Variation 39.361	9.082 Hours Geometric Coefficient of Variation 25.356	10.713 Hours Geometric Coefficient of Variation 23.782	16.337 Hours Geometric Coefficient of Variation 27.365	44.018 Hours Geometric Coefficient of Variation NA Not calculable due to only 1 participant being analyzed.	12.378 Hours Geometric Coefficient of Variation 10.948	14.060 Hours Geometric Coefficient of Variation 28.874	12.246 Hours Geometric Coefficient of Variation 38.286	7.321 Hours Geometric Coefficient of Variation 8.094	16.413 Hours Geometric Coefficient of Variation 28.186	12.561 Hours Geometric Coefficient of Variation 38.983

Deaths: 24 deaths

Serious adverse events

Serious adverse events
Measure	Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=32 participants at risk Participants were administered onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle.
Infections and infestations Lung infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Pneumonia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Septic shock	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	40.0% 2/5 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	83.3% 5/6 • Number of events 10 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 8/32 • Number of events 8 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Asthenia	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Oedema peripheral	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Neutrophil count decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Urine output decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Seroma	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	15.6% 5/32 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemic infiltration pulmonary	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Sepsis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Escherichia bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Appendicitis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Candida infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Cellulitis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Granulicatella bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Kidney infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Klebsiella bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Pneumonia fungal	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Serratia bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Skin infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Soft tissue infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Colitis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Mallory-Weiss syndrome	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Melaena	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Neutropenic colitis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Pulmonary mass	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Palmar-plantar erythodysaesthesia syndrome	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Aphasia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Psychiatric disorders Mental status changes	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Renal and urinary disorders Haematuria	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.

Other adverse events

Other adverse events
Measure	Phase 1b: Onvansertib 12 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Low-dose Cytarabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Low-dose Cytarabine n=5 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with cytarabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 12 mg/m^2 + Decitabine n=4 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 18 mg/m^2 + Decitabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 27 mg/m^2 + Decitabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 40 mg/m^2 + Decitabine n=4 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 60 mg/m^2 + Decitabine n=3 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 1b: Onvansertib 90 mg/m^2 + Decitabine n=6 participants at risk Participants were administered escalating doses of onvansertib starting at 12mg/m\^2 on Day 1 up to Day 5 of each cycle (where each cycle is 28 days) in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle, in order to determine the recommended phase 2 dose (RP2D) of onvansertib.	Phase 2: Onvansertib 60 mg/m^2 + Decitabine n=32 participants at risk Participants were administered onvansertib at the recommended phase 2 dose (RP2D) on Day 1 up to Day 5 of each cycle (where each cycle is 28 days), in combination with decitabine at a dose of 20mg/m\^2 once daily on Day 1 up to day 10 of each cycle.
Nervous system disorders Dysgeusia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Lethargy	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Tremor	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Fatigue	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 3/6 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 8/32 • Number of events 8 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Asthenia	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Oedema peripheral	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	40.0% 2/5 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	18.8% 6/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Chills	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Face oedema	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Injection site pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Oedema	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	28.1% 9/32 • Number of events 10 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Constipation	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	100.0% 3/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 4/6 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	21.9% 7/32 • Number of events 9 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Stomatitis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 3/6 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	28.1% 9/32 • Number of events 10 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Gingival bleeding	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Lung infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Oral candidiasis	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Cellulitis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Sepsis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	15.6% 5/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Headache	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Dizziness	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	75.0% 3/4 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	15.6% 5/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	15.6% 5/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	21.9% 7/32 • Number of events 9 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Increased bronchial secretion	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Orthopnoea	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Pharyngeal oedema	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Stridor	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 7 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Blood and lymphatic system disorders Febrile neutropenia	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	40.0% 2/5 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	75.0% 3/4 • Number of events 7 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	83.3% 5/6 • Number of events 10 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	37.5% 12/32 • Number of events 14 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Blood and lymphatic system disorders Thrombocytopenia	33.3% 1/3 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	40.0% 2/5 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 4/6 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	18.8% 6/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Dermatitis bullous	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Onychoclasis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Red man syndrome	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Platelet count decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	18.8% 6/32 • Number of events 9 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Neutrophil count decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Alanine aminotransferase increased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Blood alkaline phosphatase	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Blood bilirubin increased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Haemoglobin decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Urine output decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Weight decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Psychiatric disorders Confusional state	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	40.0% 2/5 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Psychiatric disorders Agitation	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Psychiatric disorders Anxiety	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Psychiatric disorders Insomnia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Psychiatric disorders Restlessness	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Fall	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Arthropod bite	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Contusion	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Laceration	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Seroma	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Transfusion reaction	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	20.0% 1/5 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Back pain	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Muscle haemorrhage	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Pain in extremity	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Cardiac disorders Atrial fibrillation	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Eye disorders Eye pruritus	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Eye disorders Photophobia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Eye disorders Visual acuity reduced	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Renal and urinary disorders Haematuria	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Renal and urinary disorders Pollakiuria	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Ear and labyrinth disorders Otorrhoea	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Ear and labyrinth disorders Tinnitus	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	15.6% 5/32 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Leukaemic infiltration pulmonary	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Reproductive system and breast disorders Sexual dysfunction	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Vascular disorders Hot flush	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Vascular disorders Hypotension	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Vomiting	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 3/6 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Lower gastrointestinal haemorrhage	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Oral pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Haematemesis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Odynophagia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Proctalgia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Escherichia bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Staphylococcal bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Staphylococcal infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Urinary tract infection	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Bacteraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Pneumonia fungal	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations White blood cell count decreased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Blood creatine increased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Aspartate aminotransferase increased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Electrocardiogram QT prolonged	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Investigations Blood urea increased	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 7 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 3/6 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Purpora	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Respiratory, thoracic and mediastinal disorders Lung consolidation	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Mucosal inflammation	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
General disorders Non-cardiac chest pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 2/6 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	31.2% 10/32 • Number of events 11 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	15.6% 5/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	15.6% 5/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 10 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	50.0% 2/4 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Fluid overload	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	66.7% 2/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Musculoskeletal and connective tissue disorders Pain in jaw	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Syncope	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Vascular disorders Hypertension	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	12.5% 4/32 • Number of events 4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Vascular disorders Haematoma	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Vascular disorders Flushing	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/32 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Eye disorders Conjunctival haemorrhage	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Ear and labyrinth disorders Ear pain	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	6.2% 2/32 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Nervous system disorders Aphasia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Septic shock	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/6 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	3.1% 1/32 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.
Infections and infestations Pneumonia	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 2 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/5 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/4 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	0.00% 0/3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	25.0% 1/4 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	33.3% 1/3 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	16.7% 1/6 • Number of events 1 • 27 months Participants included in the Safety Analysis Set were included in this analysis.	9.4% 3/32 • Number of events 3 • 27 months Participants included in the Safety Analysis Set were included in this analysis.

Additional Information

Nancy Sherman, Head of Clinical Operations

Cardiff Oncology

Phone: 858-952-7570

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place