Trial Outcomes & Findings for Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL) (NCT NCT05557942)

Last Updated: 2024-10-10

Results Overview

An Adverse Event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. Serious Adverse Events (SAEs) were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

Recruitment status

TERMINATED

Study phase

PHASE3

Target enrollment

186 participants

Primary outcome timeframe

From date of first dose to 30 days after date of last dose (up to approximately 21 months)

Results posted on

2024-10-10

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo Crossover AV-101 10 mg Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.	Placebo Crossover AV-101 35 mg Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 70 mg Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.	Continuing AV-101 10 mg Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Continuing AV-101 35 mg Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Continuing AV-101 70 mg Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Overall Study STARTED	18	18	16	45	48	41
Overall Study Received at Least 1 Dose of Study Drug	18	18	16	45	48	41
Overall Study COMPLETED	0	0	0	0	0	0
Overall Study NOT COMPLETED	18	18	16	45	48	41

Reasons for withdrawal

Reasons for withdrawal
Measure	Placebo Crossover AV-101 10 mg Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 milligrams (mg) administered twice daily (BID) via dry powder inhalation.	Placebo Crossover AV-101 35 mg Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 70 mg Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.	Continuing AV-101 10 mg Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Continuing AV-101 35 mg Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Continuing AV-101 70 mg Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Overall Study Death	0	0	0	2	1	1
Overall Study Physician Decision	1	1	2	3	0	2
Overall Study Study terminated by sponsor	17	17	14	40	45	37
Overall Study Protocol Violation	0	0	0	0	0	1
Overall Study Withdrawal by Subject	0	0	0	0	2	0

Baseline Characteristics

Inhaled Imatinib Pulmonary Arterial Hypertension Clinical Trial - Follow Up Long Term Extension (IMPAHCT-FUL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo Crossover AV-101 10 mg n=18 Participants Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 35 mg n=18 Participants Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 70 mg n=16 Participants Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.	Continuing AV-101 10 mg n=45 Participants Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Continuing AV-101 35 mg n=48 Participants Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Continuing AV-101 70 mg n=41 Participants Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.	Total n=186 Participants Total of all reporting groups
Age, Continuous	49.1 years STANDARD_DEVIATION 12.45 • n=5 Participants	45.9 years STANDARD_DEVIATION 13.17 • n=7 Participants	47.9 years STANDARD_DEVIATION 11.02 • n=5 Participants	45.5 years STANDARD_DEVIATION 12.70 • n=4 Participants	47.4 years STANDARD_DEVIATION 13.98 • n=21 Participants	46.4 years STANDARD_DEVIATION 12.80 • n=8 Participants	46.8 years STANDARD_DEVIATION 12.83 • n=8 Participants
Sex: Female, Male Female	15 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	34 Participants n=4 Participants	38 Participants n=21 Participants	35 Participants n=8 Participants	150 Participants n=8 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	10 Participants n=21 Participants	6 Participants n=8 Participants	36 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	10 Participants n=21 Participants	12 Participants n=8 Participants	39 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants	14 Participants n=7 Participants	12 Participants n=5 Participants	31 Participants n=4 Participants	34 Participants n=21 Participants	27 Participants n=8 Participants	132 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	15 Participants n=8 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	8 Participants n=7 Participants	3 Participants n=5 Participants	11 Participants n=4 Participants	12 Participants n=21 Participants	9 Participants n=8 Participants	45 Participants n=8 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	8 Participants n=8 Participants
Race (NIH/OMB) White	15 Participants n=5 Participants	8 Participants n=7 Participants	11 Participants n=5 Participants	27 Participants n=4 Participants	31 Participants n=21 Participants	24 Participants n=8 Participants	116 Participants n=8 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	5 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	13 Participants n=8 Participants

PRIMARY outcome

Timeframe: From date of first dose to 30 days after date of last dose (up to approximately 21 months)

Population: The Safety Analysis Set included all participants that received at least one dose of study drug.

Outcome measures

Outcome measures
Measure	Placebo Crossover AV-101 10 mg n=18 Participants Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 35 mg n=18 Participants Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 70 mg n=16 Participants Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.	Continuing AV-101 10 mg n=45 Participants Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Continuing AV-101 35 mg n=48 Participants Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Continuing AV-101 70 mg n=41 Participants Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Number of Participants With Treatment-emergent Adverse Events	9 Participants	11 Participants	12 Participants	26 Participants	25 Participants	21 Participants

Adverse Events

Placebo Crossover AV-101 10 mg

Serious events: 3 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo Crossover AV-101 35 mg

Serious events: 4 serious events

Other events: 11 other events

Deaths: 0 deaths

Placebo Crossover AV-101 70 mg

Serious events: 6 serious events

Other events: 10 other events

Deaths: 0 deaths

Continuing AV-101 10 mg

Serious events: 12 serious events

Other events: 17 other events

Deaths: 2 deaths

Continuing AV-101 35 mg

Serious events: 9 serious events

Other events: 19 other events

Deaths: 1 deaths

Continuing AV-101 70 mg

Serious events: 7 serious events

Other events: 15 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Placebo Crossover AV-101 10 mg n=18 participants at risk Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 35 mg n=18 participants at risk Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 70 mg n=16 participants at risk Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.	Continuing AV-101 10 mg n=45 participants at risk Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Continuing AV-101 35 mg n=48 participants at risk Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Continuing AV-101 70 mg n=41 participants at risk Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Right ventricular failure	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.7% 3/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.2% 2/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.9% 2/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Cardiac arrest	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Cardiac failure acute	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Ventricular arrhythmia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Enteritis	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Haematochezia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Catheter site haemorrhage	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Chest pain	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Influenza	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Gastroenteritis	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Acute sinusitis	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Atypical pneumonia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Device related infection	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Perineal abscess	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Pulmonary tuberculosis	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Septic shock	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Vascular device infection	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Bone lesion	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Syncope	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Pregnancy, puerperium and perinatal conditions Ectopic pregnancy	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Product Issues Device breakage	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Haemoptysis	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Lung hernia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.

Other adverse events

Other adverse events
Measure	Placebo Crossover AV-101 10 mg n=18 participants at risk Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 35 mg n=18 participants at risk Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Placebo Crossover AV-101 70 mg n=16 participants at risk Participants who previously received placebo in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.	Continuing AV-101 10 mg n=45 participants at risk Participants who previously received AV-101 10 mg in AV-101-002 received AV-101 (imatinib) 10 mg administered BID via dry powder inhalation.	Continuing AV-101 35 mg n=48 participants at risk Participants who previously received AV-101 35 mg in AV-101-002 received AV-101 (imatinib) 35 mg administered BID via dry powder inhalation.	Continuing AV-101 70 mg n=41 participants at risk Participants who previously received AV-101 70 mg in AV-101-002 received AV-101 (imatinib) 70 mg administered BID via dry powder inhalation.
Infections and infestations Viral upper respiratory tract infection	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 3/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Upper respiratory tract infection	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	9.8% 4/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations COVID-19	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.2% 2/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	7.3% 3/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Influenza	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.2% 2/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Nasopharyngitis	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Pneumonia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Respiratory tract infection	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Atypical pneumonia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Bronchitis	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Bronchitis bacterial	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Clostridium difficile colitis	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Otitis media acute	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Serratia sepsis	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Infections and infestations Transmission of an infectious agent via transplant	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 3/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	43.8% 7/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	8.3% 4/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.9% 2/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pulmonary arterial hypertension	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.2% 2/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea at rest	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Nasal dryness	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Pleural effusion	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	16.7% 3/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	9.8% 4/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Nausea	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.7% 3/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal distension	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Vomiting	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Abdominal pain upper	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Constipation	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dry mouth	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Dyspepsia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Gastrointestinal disorders Gastric disorder	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Headache	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	11.1% 5/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.2% 2/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	7.3% 3/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Dizziness	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Dysgeusia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	18.8% 3/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Metabolic encephalopathy	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Neuropathy peripheral	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Paraesthesia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Nervous system disorders Syncope	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Oedema peripheral	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.9% 2/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Fatigue	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Chest discomfort	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Catheter site haemorrhage	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Infusion site reaction	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
General disorders Pain	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	12.5% 2/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Joint stiffness	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Musculoskeletal and connective tissue disorders Myalgia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Blood creatinine increased	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Brain natriuretic peptide increased	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations N-terminal prohormone brain natriuretic peptide increased	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Oxygen saturation decreased	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Platelet count decreased	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Blood glucose decreased	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Blood uric acid increased	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Forced expiratory volume decreased	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Glomerular filtration rate decreased	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Heart rate increased	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Neutrophil count decreased	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations Weight decreased	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Investigations White blood cell count decreased	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypokalaemia	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Iron deficiency	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.4% 2/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Fluid retention	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperglycaemia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hyperkalaemia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoalbuminaemia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Metabolism and nutrition disorders Hypoglycaemia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Thrombocytopenia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.9% 2/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Blood loss anaemia	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Coagulopathy	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Palpitations	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	4.2% 2/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Pericardial effusion	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.2% 1/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Tachycardia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	11.1% 2/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Pulmonary valve incompetence	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Cardiac disorders Supraventricular tachycardia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Procedural pain	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Complications of transplanted lung	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Incision site pain	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Transplant dysfunction	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Injury, poisoning and procedural complications Wound haemorrhage	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.4% 1/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Skin and subcutaneous tissue disorders Rash maculo-papular	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Ear and labyrinth disorders Vertigo	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	6.2% 1/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Psychiatric disorders Anxiety	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Psychiatric disorders Insomnia	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Vascular disorders Hypotension	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	2.1% 1/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Hepatobiliary disorders Liver injury	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Uterine leiomyoma	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.
Renal and urinary disorders Bladder irritation	0.00% 0/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	5.6% 1/18 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/16 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/45 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/48 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.	0.00% 0/41 • From date of first dose to date of last dose plus 30 days (up to approximately 21 months) The safety analysis set included all participants who received at least one dose of study drug.

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