Trial Outcomes & Findings for A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems (NCT NCT03814005)

NCT ID: NCT03814005

Last Updated: 2024-09-05

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

17 participants

Primary outcome timeframe

Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Results posted on

2024-09-05

Participant Flow

Participants took part in the study at 5 investigative sites in United States and Spain from 10 July 2019 to 19 April 2022.

Participants with myelodysplastic syndromes (MDS), and acute myelogenous leukemia (AML) who also had severe renal impairment or mild hepatic impairment were enrolled in this study to receive single dose of pevonedistat in Part A followed by a wash out period and pevonedistat in combination with standard of care agent in Part B. No participants with chronic myelomonocytic leukemia (CMML) and solid tumors were enrolled in this study.

Participant milestones

Participant milestones
Measure	Control Arm Pevonedistat 20 mg/m\^2, infusion, intravenously (IV), once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously (SC) in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Renal Arm Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 15 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Mild Hepatic Arm Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part A: Day 1 to Day 4 STARTED	10	4	3
Part A: Day 1 to Day 4 Response-evaluable Population	8	1	2
Part A: Day 1 to Day 4 COMPLETED	10	4	3
Part A: Day 1 to Day 4 NOT COMPLETED	0	0	0
Washout Period : Day 4 to Day 7 STARTED	10	4	3
Washout Period : Day 4 to Day 7 COMPLETED	10	4	3
Washout Period : Day 4 to Day 7 NOT COMPLETED	0	0	0
Part B: Day 8 to Day 343 STARTED	10	4	3
Part B: Day 8 to Day 343 COMPLETED	0	0	0
Part B: Day 8 to Day 343 NOT COMPLETED	10	4	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Control Arm Pevonedistat 20 mg/m\^2, infusion, intravenously (IV), once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously (SC) in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Renal Arm Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 15 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Mild Hepatic Arm Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B: Day 8 to Day 343 Adverse Event	2	0	0
Part B: Day 8 to Day 343 Withdrawal by Subject	0	0	3
Part B: Day 8 to Day 343 Progressive Disease	4	2	0
Part B: Day 8 to Day 343 Unsatisfactory Therapeutic Response	2	0	0
Part B: Day 8 to Day 343 Symptomatic Deterioration	1	2	0
Part B: Day 8 to Day 343 Reason not Specified	1	0	0

Baseline Characteristics

A Study of Pevonedistat in People With Blood Cancers or Solid Tumors With Kidney or Liver Problems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Control Arm n=10 Participants Pevonedistat 20 milligram per square meter (mg/m\^2), infusion, intravenously (IV), once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously (SC) in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Renal Arm n=4 Participants Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 15 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Mild Hepatic Arm n=3 Participants Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days. Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Total n=17 Participants Total of all reporting groups
Age, Continuous	70.1 years STANDARD_DEVIATION 11.75 • n=5 Participants	71.5 years STANDARD_DEVIATION 6.86 • n=7 Participants	79.7 years STANDARD_DEVIATION 3.06 • n=5 Participants	72.1 years STANDARD_DEVIATION 10.05 • n=4 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Male	10 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	15 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	17 Participants n=4 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
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
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 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
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race (NIH/OMB) White	8 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	14 Participants n=4 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
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	6 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	11 Participants n=4 Participants
Region of Enrollment Spain	4 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants
Height	170.3 centimeter (cm) STANDARD_DEVIATION 5.99 • n=5 Participants	175.0 centimeter (cm) STANDARD_DEVIATION 11.13 • n=7 Participants	170.2 centimeter (cm) STANDARD_DEVIATION 22.00 • n=5 Participants	171.4 centimeter (cm) STANDARD_DEVIATION 10.40 • n=4 Participants
Weight	75.0 kilogram (kg) STANDARD_DEVIATION 7.77 • n=5 Participants	74.5 kilogram (kg) STANDARD_DEVIATION 14.21 • n=7 Participants	71.7 kilogram (kg) STANDARD_DEVIATION 19.43 • n=5 Participants	74.3 kilogram (kg) STANDARD_DEVIATION 10.98 • n=4 Participants

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Population: Pharmacokinetic (PK) population included all participants who had sufficient dosing in Part A and Part B Cycle 1, had sufficient concentration-time data to permit reliable estimation of PK parameters, and who had not received any excluded concomitant medications through the completion of Part A.

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part A, AUC∞: Area Under the Plasma Concentration-time Curve From Time Zero to Infinity for Pevonedistat Following a Single Dose	1168.616 hournanogram per milliliter(hng/mL) Geometric Coefficient of Variation 69.4811	1293.467 hournanogram per milliliter(hng/mL) Geometric Coefficient of Variation 22.0685	1050.553 hournanogram per milliliter(hng/mL) Geometric Coefficient of Variation 69.4854	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Population: PK population included all participants who had sufficient dosing in Part A and Part B Cycle 1, had sufficient concentration-time data to permit reliable estimation of PK parameters, and who had not received any excluded concomitant medications through the completion of Part A.

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part A, AUClast: Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration for Pevonedistat Following a Single Dose	1120.759 h*ng/mL Geometric Coefficient of Variation 73.3956	1267.523 h*ng/mL Geometric Coefficient of Variation 22.1528	1020.344 h*ng/mL Geometric Coefficient of Variation 71.9314	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part A, Cmax: Maximum Observed Plasma Concentration for Pevonedistat Following a Single Dose	262.9 nanograms per milliliter(ng/mL) Geometric Coefficient of Variation 188.54	180.2 nanograms per milliliter(ng/mL) Geometric Coefficient of Variation 37.66	148.9 nanograms per milliliter(ng/mL) Geometric Coefficient of Variation 30.09	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part A: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Part B: Cycle 1 Day 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=3 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=2 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 n=10 Participants Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Parts A and B, t1/2z: Terminal Disposition Phase Half-life for Pevonedistat Following Single and Multiple Dose	6.957 hours (h) Interval 4.25 to 13.88	8.493 hours (h) Interval 7.31 to 10.29	9.612 hours (h) Interval 7.49 to 11.03	—	8.795 hours (h) Interval 7.03 to 9.22	10.248 hours (h) Interval 9.78 to 10.72	—	8.98 hours (h) Interval 8.98 to 8.98	—	6.477 hours (h) Interval 3.93 to 13.37	—	6.79 hours (h) Interval 6.79 to 6.79

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=10 Participants Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B: Cmax: Maximum Observed Plasma Concentration for Pevonedistat Following Multiple Dose	—	74.73 ng/mL Geometric Coefficient of Variation 14.941	44.74 ng/mL Geometric Coefficient of Variation 24.579	—	128.00 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the lower limit of quantitation (LLOQ) of the bioanalytical assay.	—	141.55 ng/mL Geometric Coefficient of Variation 37.468	—	75.80 ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.	—	—	—

SECONDARY outcome

Timeframe: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Parts A, fu: Fraction of Unbound Drug in Plasma for Pevonedistat	5.800 percentage of plasma fraction unbound Geometric Coefficient of Variation 18.2880	7.073 percentage of plasma fraction unbound Geometric Coefficient of Variation 12.2269	5.529 percentage of plasma fraction unbound Geometric Coefficient of Variation 2.0462	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 7 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, Cmax: Maximum Observed Plasma Concentration for Azacitidine Following Multiple Dose	645.4 ng/mL Geometric Coefficient of Variation 34.40	918.6 ng/mL Geometric Coefficient of Variation 98.14	834.8 ng/mL Geometric Coefficient of Variation 38.23	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 7 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, Tmax: Time to Reach the Maximum Plasma Concentration (Cmax) for Azacitidine Following Multiple Dose	0.325 hours (h) Interval 0.08 to 0.75	0.500 hours (h) Interval 0.32 to 0.53	0.250 hours (h) Interval 0.12 to 0.75	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 7 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, t1/2z: Terminal Disposition Phase Half-life for Azacitidine Following Multiple-dose	0.706 hours (h) Interval 0.57 to 1.47	1.020 hours (h) Interval 0.79 to 1.76	0.694 hours (h) Interval 0.67 to 1.13	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=10 Participants Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, AUCτ: Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval for Pevonedistat Following Multiple Dose	—	574.168 h*ng/mL Geometric Coefficient of Variation 19.6797	396.240 h*ng/mL Geometric Coefficient of Variation 14.4663	—	884.974 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.	—	848.866 h*ng/mL Geometric Coefficient of Variation 25.6831	—	431.699 h*ng/mL Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 7 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, AUCτ: Area Under the Concentration-time Curve From Time Zero to the End of the Dosing Interval for Azacitidine Following Multiple Dose	822.457 h*ng/mL Geometric Coefficient of Variation 31.1338	1331.654 h*ng/mL Geometric Coefficient of Variation 63.1278	751.448 h*ng/mL Geometric Coefficient of Variation 35.3760	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part A: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Part B: Cycle 1 Day 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length is 28 Days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=3 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=2 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 n=10 Participants Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Parts A and B, CL: Total Clearance for Pevonedistat	32.149 liters per hour (L/h) Geometric Coefficient of Variation 64.5489	29.167 liters per hour (L/h) Geometric Coefficient of Variation 31.5125	34.476 liters per hour (L/h) Geometric Coefficient of Variation 56.9322	—	32.721 liters per hour (L/h) Geometric Coefficient of Variation 36.0104	51.628 liters per hour (L/h) Geometric Coefficient of Variation 9.1794	—	32.361 liters per hour (L/h) Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.	—	44.259 liters per hour (L/h) Geometric Coefficient of Variation 24.9426	—	65.746 liters per hour (L/h) Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, CL/F: Apparent Clearance for Azacitidine	171.301 L/h Geometric Coefficient of Variation 34.6321	106.238 L/h Geometric Coefficient of Variation 74.8634	180.744 L/h Geometric Coefficient of Variation 21.1071	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=10 Participants Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, CLR: Renal Clearance for Pevonedistat	—	0.298 L/h Geometric Coefficient of Variation 51.0558	0.492 L/h Geometric Coefficient of Variation 36.0553	—	0.069 L/h Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.	—	0.516 L/h Geometric Coefficient of Variation 147.7469	—	0.062 L/h Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.	—	—	—

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, CLR: Renal Clearance for Azacitidine	0.909 L/h Geometric Coefficient of Variation 134.3959	0.161 L/h Geometric Coefficient of Variation 207.8515	0.445 L/h Geometric Coefficient of Variation 167.4353	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Part A: Day 1 pre-dose and at multiple time points (up to 72 hours) post-dose; Part B: Cycle 1 Day 3 pre-dose and at multiple time points (up to 48 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=3 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 n=2 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 n=10 Participants Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 n=1 Participants Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Parts A and B, Vss: Volume of Distribution at Steady-state of Pevonedistat	219.288 Liters (L) Geometric Coefficient of Variation 124.3584	293.614 Liters (L) Geometric Coefficient of Variation 36.3707	353.570 Liters (L) Geometric Coefficient of Variation 55.0197	—	351.749 Liters (L) Geometric Coefficient of Variation 23.5066	729.013 Liters (L) Geometric Coefficient of Variation 3.2642	—	336.922 Liters (L) Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.	—	370.563 Liters (L) Geometric Coefficient of Variation 44.2326	—	573.044 Liters (L) Geometric Coefficient of Variation NA Geometric coefficient of variation was not estimable for 1 participant as the values were below the LLOQ of the bioanalytical assay.

SECONDARY outcome

Timeframe: Cycle 1 Day 3 pre-dose and at multiple time points (up to 8 hours) post-dose (Cycle length= 28 days)

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=10 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=3 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B, Vz/F: Apparent Volume of Distribution of Azacitidine	190.871 L Geometric Coefficient of Variation 60.0093	167.610 L Geometric Coefficient of Variation 92.9284	211.139 L Geometric Coefficient of Variation 8.4099	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles (up to 2 years 9 months) (Cycle length= 28 days)

Population: Response-evaluable population included participants who received at least 1 dose of study drug, had a baseline disease assessment, and had at least 1 postbaseline disease assessment to analyze response. Percentages are rounded off to whole number at the nearest decimal.

Disease response in AML are based on international working group (IWG) for diagnosis, standardization of response criteria, treatment outcomes, and reporting standards for therapeutic trials in AML. For AML participants, all CR includes both CR and CRi. CR: morphologic leukemia-free state with absolute neutrophil count (ANC) of greater than (\>) 1000 per microliter (/mcL) and platelets of greater than or equal to (\>=) 100,000/mcL, and no residual evidence of extramedullary leukemia. CRi: After chemotherapy, some participants fulfill all criteria for CR except for residual neutropenia (less than \[\<\] 1000/mcL) or thrombocytopenia (\<100,000/mcL). PR: requires all hematologic values for a CR but with a decrease of at least 50 percent (%) in the percentage of blasts to 5% to 25% in the bone marrow aspirate. A value of less than or equal to (\<=) 5% blasts may also be considered a PR if Auer rods are present.

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=8 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=1 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B: Percentage of AML Participants With Complete Response/ Remission (CR) or CR With Incomplete Blood Count Recovery (CRi) or Partial Response (PR) CR or CRi	13 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—
Part B: Percentage of AML Participants With Complete Response/ Remission (CR) or CR With Incomplete Blood Count Recovery (CRi) or Partial Response (PR) PR	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles (up to 2 years 9 months) (Cycle length= 28 days)

Disease response in MDS and CMML was based on best overall response (CR+PR+HI) as determined by investigator using revised IWG response criteria for MDS and CMML. CR: morphologic leukemia-free state with absolute neutrophil count (ANC) of greater than (\>) 1000 per microliter (/mcL) and platelets of greater than or equal to (\>=) 100,000/mcL, and no residual evidence of extramedullary leukemia. PR: requires all hematologic values for a CR but with a decrease of at least 50 percent (%) in the percentage of blasts to 5% to 25% in the bone marrow aspirate. A value of less than or equal to (\<=) 5% blasts may also be considered a PR if Auer rods are present. HI: erythropoietic (HI-E): Hemoglobin increase of ≥ 1.5 g/dL untransfused, for red blood cells (RBC) transfusions performed for hemoglobin ≤ 9.0: reduction in RBC units transfused in 8 weeks by ≥ 4 units compared to the number of units transfused in the 8 weeks prior to treatment. No participants with CMML were enrolled in this study.

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=8 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=1 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B: Percentage of MDS and CMML Participants With CR, PR or Hematologic Improvement (HI) MDS CR	38 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—
Part B: Percentage of MDS and CMML Participants With CR, PR or Hematologic Improvement (HI) MDS PR	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—
Part B: Percentage of MDS and CMML Participants With CR, PR or Hematologic Improvement (HI) MDS HI	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles (up to 2 years 9 months) (Cycle length= 28 days)

Overall Response Rate is defined as CR+CRi+PR+HI. CR:≤5% myeloblasts with normal maturation of all bone marrow(BM)cell lines,≥11g/dL Hgb,≥100\*10\^9/L pl,≥1.0\*10\^9/L neutrophils,0% blasts in peripheral blood;PR:all CR criteria met except BM blasts ≥50% decrease over pretreatment but still \>5%;HI:Hgb increase(inc) ≥1.5g/dL if baseline(BL)\<11 g/dL;pl inc≥30\*10\^9/L if BL\>20\*10\^9/L or inc from \<20\*10\^9/L to \>20\*10\^9/L and by 100%;neutrophil inc by 100%;absolute inc of \>0.5\*10\^9/L if BL\<100\*10\^9/L.For AML-CR:morphologic leukemia-free state \>1.0\*10\^9 neutrophils,≥100\*10\^9/L pl,transfusion independence,no residual evidence of extramedullary leukemia;CR with incomplete blood count recovery:fulfill CR criteria except residual neutropenia (\<1000/μL) or thrombocytopenia (\<100,000/μL);PR:all CR hematological values but ≥50% decrease in BM aspirate.

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=8 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 n=1 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 n=2 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B: Percentage of HR MDS and AML Participants With Overall Response	50 percentage of participants	0 percentage of participants	0 percentage of participants	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: From first documentation of response up to disease progression (up to 2 years 9 months)

Population: Response-evaluable population included participants who received at least 1 dose of study drug, had a baseline disease assessment, and had at least 1 postbaseline disease assessment to analyze response. Overall number of participants analyzed is the number of participants with disease response (CR+PR+HI) for hematologic malignancies.

Duration of response in participants with disease response (CR+PR+HI) for hematologic malignancies is time between first documentation of response and disease progression. Duration of response will be determined by the investigator using the revised IWG response criteria.

Outcome measures

Outcome measures
Measure	Part A: Control Arm: Pevonedistat 20 mg/m^2 n=4 Participants Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with normal renal and hepatic function with hematologic malignancies (MDS and AML).	Part A: Renal Arm: Pevonedistat 20 mg/m^2 Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with severe renal impairment with hematologic malignancies (MDS and AML).	Part A: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 Pevonedistat 20 mg/m\^2, infusion, IV, once, on Day 1 of Part A in participants with mild hepatic impairment with and hematologic malignancies (MDS and AML).	Part B: Control Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 10 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 10 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 15 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 15 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Control Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with normal renal and hepatic function with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with severe renal impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm: Pevonedistat 20 mg/m^2 + Azacitidine 75 mg/m^2 Participants with mild hepatic impairment with hematologic malignancies (MDS and AML) who completed Part A and a 4 to 7 days of washout period received pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in combination with azacitidine 75 mg/m\^2, injection, SC in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Part B: Duration of CR, PR and HI	NA days Data for median and full range was not estimable due to insufficient number of participants with events (i.e., disease progression).	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Cycle 2 Day 22, Cycles 5, 8, and 11 (between Days 15 and 28), and every 6 cycles (up to 2 years 9 months) (Cycle length= 28 days)

Population: No participants with solid tumors were enrolled in this study.

Disease response in solid tumors was based on best overall response (CR+PR) as determined by investigator using the RECIST version 1.1 criteria. CR: disappearance of all target lesions with any pathological lymph nodes (whether target or nontarget) must have reduction in short axis to \<10 millimeter (mm) and disappearance of all nontarget lesions and normalization of tumor marker level with all lymph nodes must be nonpathological in size (\<10 mm short axis); PR: At least a 30% decrease from baseline in the sum of diameters of target lesions, taking as reference the baseline sum of diameters and Persistence of one or more nontarget lesion(s) or/and maintenance of tumor marker level above the normal limits. No participants with solid tumors were enrolled in this study.

Outcome measures

Outcome data not reported

Adverse Events

Part A: Control Arm

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Part A: Renal Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part A: Mild Hepatic Arm

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Part B: Control Arm

Serious events: 7 serious events

Other events: 10 other events

Deaths: 2 deaths

Part B: Renal Arm

Serious events: 3 serious events

Other events: 4 other events

Deaths: 2 deaths

Part B: Mild Hepatic Arm

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Control Arm n=10 participants at risk Pevonedistat 20 milligram per square meter (mg/m\^2), infusion, intravenously (IV), once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days.	Part A: Renal Arm n=4 participants at risk Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with renal hematologic malignancies, followed by a washout period of approximately 4 to 7 days.	Part A: Mild Hepatic Arm n=3 participants at risk Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with mild hematologic malignancies, followed by a washout period of approximately 4 to 7 days.	Part B: Control Arm n=10 participants at risk Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously (SC) in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm n=4 participants at risk Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 15 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with renal hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm n=3 participants at risk Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with mild hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Renal and urinary disorders Acute kidney injury	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	50.0% 2/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Bladder transitional cell carcinoma	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Chronic kidney disease	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Escherichia bacteraemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Fatigue	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	30.0% 3/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Nervous system disorders Haemorrhage intracranial	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Klebsiella bacteraemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Pneumonia pseudomonal	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Pneumonia staphylococcal	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Pyrexia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Sepsis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Sinusitis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Thyroid gland abscess	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Tumour lysis syndrome	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Urinary tract infection	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations White blood cell count increased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.

Other adverse events

Other adverse events
Measure	Part A: Control Arm n=10 participants at risk Pevonedistat 20 milligram per square meter (mg/m\^2), infusion, intravenously (IV), once, on Day 1 of Part A in participants with hematologic malignancies, followed by a washout period of approximately 4 to 7 days.	Part A: Renal Arm n=4 participants at risk Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with renal hematologic malignancies, followed by a washout period of approximately 4 to 7 days.	Part A: Mild Hepatic Arm n=3 participants at risk Pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Day 1 of Part A in participants with mild hematologic malignancies, followed by a washout period of approximately 4 to 7 days.	Part B: Control Arm n=10 participants at risk Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously (SC) in Cycle 1 or SC or IV in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with pevonedistat 20 mg/m\^2, infusion, IV, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Renal Arm n=4 participants at risk Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8-9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 15 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with renal hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.	Part B: Mild Hepatic Arm n=3 participants at risk Following Part A participants received azacitidine 75 mg/m\^2, injection, subcutaneously in Cycle 1 or subcutaneously or intravenously in Cycle 2 and subsequent cycles, once on Day 1 through Day 7 or Day 1 through Day 5, and on Days 8 and 9 in combination with a starting dose of pevonedistat 10 mg/m\^2 to a maximum dose of pevonedistat 20 mg/m\^2, infusion, intravenously, once, on Days 1, 3, and 5 in each 28-day treatment cycle in participants with mild hematologic malignancies in Part B until symptomatic deterioration or PD, discontinuation for any reason, study stopped by the sponsor, or up to 12 cycles.
Metabolism and nutrition disorders Acidosis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations Alanine aminotransferase increased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Blood and lymphatic system disorders Anaemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	50.0% 2/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Anal infection	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Psychiatric disorders Anxiety	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Aphthous ulcer	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations Aspartate aminotransferase increased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Asthenia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	30.0% 3/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Bladder spasm	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations Blast cell count increased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Blister	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations Blood bilirubin increased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	66.7% 2/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations Blood creatinine increased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	75.0% 3/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Bullous haemorrhagic dermatosis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Catheter site haematoma	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Cellulitis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Nervous system disorders Cognitive disorder	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Eye disorders Conjunctival haemorrhage	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	66.7% 2/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Constipation	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	30.0% 3/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	50.0% 2/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Injury, poisoning and procedural complications Contusion	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	40.0% 4/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Psychiatric disorders Depression	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Diarrhoea	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	30.0% 3/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	50.0% 2/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Nervous system disorders Dizziness	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Dry mouth	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Dyspepsia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Dysuria	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Ear and labyrinth disorders Ear pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	66.7% 2/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Escherichia bacteraemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Injury, poisoning and procedural complications Fall	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Fatigue	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	40.0% 4/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	50.0% 2/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Folliculitis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Fungal skin infection	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Furuncle	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Gingival bleeding	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Gingival pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Haematuria	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Haemorrhage subcutaneous	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Haemorrhoids	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Psychiatric disorders Hallucination	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Nervous system disorders Headache	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Herpes zoster	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Vascular disorders Hypertension	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Vascular disorders Hypotension	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Influenza like illness	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Injection site erythema	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Injection site nodule	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Injection site pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Psychiatric disorders Insomnia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations International normalised ratio increased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Keratoacanthoma	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Blood and lymphatic system disorders Leukostasis syndrome	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Lip blister	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Lip ulceration	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Nausea	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Blood and lymphatic system disorders Neutropenia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations Neutrophil count decreased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Oedema peripheral	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Oral candidiasis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Oral herpes	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Oral pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Oral purpura	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	30.0% 3/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Vascular disorders Orthostatic hypotension	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	30.0% 3/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Psychiatric disorders Panic attack	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Panniculitis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations Platelet count decreased	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Pneumonia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Pneumonia fungal	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Pollakiuria	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Nervous system disorders Presyncope	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Proctalgia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Proteinuria	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Purpura	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Pyrexia	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	60.0% 6/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	66.7% 2/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	20.0% 2/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Nervous system disorders Sinus headache	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Cardiac disorders Sinus tachycardia	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Injury, poisoning and procedural complications Skin abrasion	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Skin induration	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Skin and subcutaneous tissue disorders Skin irritation	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Injury, poisoning and procedural complications Skin laceration	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Stomatitis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Nervous system disorders Syncope	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
General disorders Systemic inflammatory response syndrome	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Musculoskeletal and connective tissue disorders Tendonitis	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Tooth infection	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Gastrointestinal disorders Toothache	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	33.3% 1/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Infections and infestations Upper respiratory tract infection	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Urethral haemorrhage	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Urinary incontinence	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	25.0% 1/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Renal and urinary disorders Urinary tract obstruction	0.00% 0/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.
Investigations White blood cell count increased	10.0% 1/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	40.0% 4/10 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/4 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.	0.00% 0/3 • From the study start up to end of study (up to approximately 2 years 9 months) At each visit investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by participant or observed by investigator was recorded, irrespective of relation to study treatment. Safety population included all participants who received at least 1 dose of study drug. As pre-specified in protocol and SAP, data for adverse events are reported separately for Part A and Part B based on their renal and/or hepatic function.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Research Organization shall not publish any articles or papers nor make any presentations, nor assist any other person in publishing any articles or papers or in making any presentations relating or referring to the Study or any results, data or insights from or any data, information or materials obtained or generated in the performance of its obligations without the prior written consent of Takeda, which consent may be granted or withheld in Takeda's sole discretion.
Publication restrictions are in place

Restriction type: OTHER