Trial Outcomes & Findings for An Open-label Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study) (NCT NCT05037851)

NCT ID: NCT05037851

Last Updated: 2026-04-30

Results Overview

Percentage of Participants Who Completed 12 Weeks of PC945 or Initial Standard of Care (SoC)

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

102 participants

Primary outcome timeframe

Week 12

Results posted on

2026-04-30

Participant Flow

Participant milestones

Participant milestones
Measure	PC945 Participants received PC945 for 12 weeks	Standard of Care (SoC) Participants received mold-active SoC
Overall Study STARTED	69	33
Overall Study Received at Least One Dose of Study Drug	65	33
Overall Study COMPLETED	59	28
Overall Study NOT COMPLETED	10	5

Reasons for withdrawal

Reasons for withdrawal
Measure	PC945 Participants received PC945 for 12 weeks	Standard of Care (SoC) Participants received mold-active SoC
Overall Study Death	1	2
Overall Study Withdrawal by Subject	7	3
Overall Study logistical or personal choice reasons	2	0

Baseline Characteristics

An Open-label Safety Study of PC945 (Opelconazole) Prophylaxis or Pre-emptive Therapy Against Pulmonary Aspergillosis in Lung Transplant Recipients (OPERA-S Study)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PC945 n=65 Participants Participants received PC945 for 12 weeks	Standard of Care n=33 Participants Participants received mold-active SoC	Total n=98 Participants Total of all reporting groups
Age, Customized 18 to <65 years	36 Participants n=14 Participants	21 Participants n=34 Participants	57 Participants n=69 Participants
Age, Customized 65 to <75 years	29 Participants n=14 Participants	12 Participants n=34 Participants	41 Participants n=69 Participants
Sex: Female, Male Female	26 Participants n=14 Participants	11 Participants n=34 Participants	37 Participants n=69 Participants
Sex: Female, Male Male	39 Participants n=14 Participants	22 Participants n=34 Participants	61 Participants n=69 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=14 Participants	3 Participants n=34 Participants	16 Participants n=69 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	48 Participants n=14 Participants	28 Participants n=34 Participants	76 Participants n=69 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=14 Participants	2 Participants n=34 Participants	6 Participants n=69 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants
Race (NIH/OMB) Asian	1 Participants n=14 Participants	0 Participants n=34 Participants	1 Participants n=69 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=14 Participants	0 Participants n=34 Participants	1 Participants n=69 Participants
Race (NIH/OMB) Black or African American	7 Participants n=14 Participants	2 Participants n=34 Participants	9 Participants n=69 Participants
Race (NIH/OMB) White	50 Participants n=14 Participants	30 Participants n=34 Participants	80 Participants n=69 Participants
Race (NIH/OMB) More than one race	0 Participants n=14 Participants	0 Participants n=34 Participants	0 Participants n=69 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=14 Participants	1 Participants n=34 Participants	7 Participants n=69 Participants

PRIMARY outcome

Timeframe: Week 12

Population: The Safety Population consisted of all randomized participants who received at least one dose of study therapy

Percentage of Participants Who Completed 12 Weeks of PC945 or Initial Standard of Care (SoC)

Outcome measures

Outcome measures
Measure	PC945 n=65 Participants Participants received PC945 for 12 weeks	Standard of Care n=33 Participants Participants received mold-active SoC
Proportion of Participants Who Completed 12 Weeks of Therapy	47 Participants	23 Participants

Adverse Events

PC945

Serious events: 27 serious events

Other events: 59 other events

Deaths: 1 deaths

Standard of Care

Serious events: 12 serious events

Other events: 27 other events

Deaths: 2 deaths

Serious adverse events

Other adverse events

Additional Information

Pulmocide Administrators

Pulmocide

Phone: +44 (0)203 763 9484

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The Sponsor has exclusive rights to the first publication via a multi-center study publication. Institutions and Investigators may publish independently only after the multi-center publication or 12 months (Sponsor's template language, for use where there is no mandated national CTA) after study completion. Independent submissions require 60 days' Sponsor review, a possible 45-day delay for IP protection, removal of confidential information, and good-faith consideration of Sponsor comments.
Publication restrictions are in place

Restriction type: OTHER

Serious adverse events
Measure	PC945 n=65 participants at risk Participants received PC945 for 12 weeks	Standard of Care n=33 participants at risk Participants received mold-active SoC
Blood and lymphatic system disorders Anaemia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Blood and lymphatic system disorders Febrile neutropenia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Cardiac disorders Arrhythmia	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Cardiac disorders Atrial fibrillation	7.7% 5/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Cardiac disorders Cardiac arrest	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Cardiac disorders Supraventricular tachycardia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Cardiac disorders Tachycardia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Eye disorders Retinal detachment	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Eye disorders Visual impairment	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Gastric stenosis	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Hiatus hernia	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Nausea	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Vomiting	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
General disorders Chest pain	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
General disorders Chills	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
General disorders Hyperthermia malignant	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Hepatobiliary disorders Cholecystitis acute	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Immune system disorders Lung transplant rejection	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Immune system disorders Transplant rejection	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Aspergillus infection	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Candida endophthalmitis	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Cytomegalovirus infection reactivation	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Diverticulitis	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Empyema	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Escherichia sepsis	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Fungal infection	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Pneumonia	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Pneumonia haemophilus	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Pneumonia staphylococcal	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Staphylococcal infection	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Injury, poisoning and procedural complications Anastomotic complication	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Injury, poisoning and procedural complications Bronchial anastomosis complication	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Injury, poisoning and procedural complications Procedural pneumothorax	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Investigations Escherichia test positive	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Investigations Immunosuppressant drug level increased	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Investigations Troponin increased	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Metabolism and nutrition disorders Hyperglycaemia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Metabolism and nutrition disorders Hyperkalaemia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Musculoskeletal and connective tissue disorders Back pain	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.

Other adverse events
Measure	PC945 n=65 participants at risk Participants received PC945 for 12 weeks	Standard of Care n=33 participants at risk Participants received mold-active SoC
Infections and infestations Oral candidiasis	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	9.1% 3/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Psychiatric disorders Depression	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Blood and lymphatic system disorders Neutropenia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Blood and lymphatic system disorders Thrombocytopenia	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Cardiac disorders Atrial fibrillation	13.8% 9/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	15.2% 5/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Constipation	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Diarrhoea	12.3% 8/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	15.2% 5/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Dysphagia	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Psychiatric disorders Hallucination	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Gastrooesophageal reflux disease	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Gastrointestinal disorders Nausea	7.7% 5/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
General disorders Oedema peripheral	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Immune system disorders Lung transplant rejection	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Psychiatric disorders Insomnia	7.7% 5/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	9.1% 3/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Immune system disorders Transplant rejection	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Asymptomatic COVID-19	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Bacterial disease carrier	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Blood and lymphatic system disorders Anaemia	9.2% 6/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Blood and lymphatic system disorders Leukocytosis	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Pneumonia bacterial	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Infections and infestations Postoperative wound infection	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Metabolism and nutrition disorders Hyperglycaemia	7.7% 5/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Metabolism and nutrition disorders Hyperkalaemia	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	12.1% 4/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Metabolism and nutrition disorders Hypomagnesaemia	7.7% 5/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Metabolism and nutrition disorders Hyponatraemia	3.1% 2/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Nervous system disorders Migraine	0.00% 0/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Psychiatric disorders Anxiety	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Psychiatric disorders Delirium	9.2% 6/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Renal and urinary disorders Acute kidney injury	9.2% 6/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	9.1% 3/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Respiratory, thoracic and mediastinal disorders Cough	7.7% 5/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Respiratory, thoracic and mediastinal disorders Dyspnoea	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.3% 8/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	3.0% 1/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Vascular disorders Deep vein thrombosis	4.6% 3/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	9.1% 3/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Vascular disorders Hypotension	1.5% 1/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	6.1% 2/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.
Nervous system disorders Tremor	6.2% 4/65 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.	0.00% 0/33 • First dose of study therapy up to Week 16 The adverse event analysis included the Safety Population, which consisted of all randomized participants who received at least one dose of study therapy. All-cause Mortality included all enrolled participants.