Trial Outcomes & Findings for Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer (NCT NCT04163900)

NCT ID: NCT04163900

Last Updated: 2023-05-24

Results Overview

Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed.

• Recruitment status: TERMINATED
• Study phase: PHASE3
• Target enrollment: 773 participants
• Primary outcome timeframe: Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months.
• Results posted on: 2023-05-24

Participant Flow

A total of 773 patients were recruited between Dec 2019 and March 2022.

Participant milestones

Measure	A - NUC-1031 and Cisplatin 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	B - Gemcitabine and Cisplatin 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
Overall Study STARTED	388	385
Overall Study Received Study Treatment (Safety Population)	383	378
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	388	385

Reasons for withdrawal

Measure	A - NUC-1031 and Cisplatin 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	B - Gemcitabine and Cisplatin 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
Overall Study Radiological disease progression	112	127
Overall Study Study closure	98	133
Overall Study Adverse Event	78	32
Overall Study Withdrawal by Subject	37	34
Overall Study Death	29	16
Overall Study Physician Decision	17	25
Overall Study Clinical disease progression	14	13
Overall Study Protocol Violation	3	4
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Comparing NUC-1031 Plus Cisplatin to Gemcitabine Plus Cisplatin in Patients With Advanced Biliary Tract Cancer

Baseline characteristics by cohort

Measure	A - NUC-1031 and Cisplatin n=388 Participants 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	B - Gemcitabine and Cisplatin n=385 Participants 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	Total n=773 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	185 Participants n=93 Participants	186 Participants n=4 Participants	371 Participants n=27 Participants
Age, Categorical >=65 years	203 Participants n=93 Participants	199 Participants n=4 Participants	402 Participants n=27 Participants
Age, Continuous	65.0 years n=93 Participants	65.0 years n=4 Participants	65.0 years n=27 Participants
Sex: Female, Male Female	174 Participants n=93 Participants	188 Participants n=4 Participants	362 Participants n=27 Participants
Sex: Female, Male Male	214 Participants n=93 Participants	197 Participants n=4 Participants	411 Participants n=27 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=93 Participants	31 Participants n=4 Participants	52 Participants n=27 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	359 Participants n=93 Participants	337 Participants n=4 Participants	696 Participants n=27 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	8 Participants n=93 Participants	17 Participants n=4 Participants	25 Participants n=27 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=93 Participants	0 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Asian	76 Participants n=93 Participants	77 Participants n=4 Participants	153 Participants n=27 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	1 Participants n=4 Participants	1 Participants n=27 Participants
Race (NIH/OMB) Black or African American	3 Participants n=93 Participants	5 Participants n=4 Participants	8 Participants n=27 Participants
Race (NIH/OMB) White	285 Participants n=93 Participants	274 Participants n=4 Participants	559 Participants n=27 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Race (NIH/OMB) Unknown or Not Reported	23 Participants n=93 Participants	28 Participants n=4 Participants	51 Participants n=27 Participants
Primary tumour location Gallbladder	80 Participants n=93 Participants	80 Participants n=4 Participants	160 Participants n=27 Participants
Primary tumour location Intra-hepatic	209 Participants n=93 Participants	207 Participants n=4 Participants	416 Participants n=27 Participants
Primary tumour location Extra-hepatic	80 Participants n=93 Participants	80 Participants n=4 Participants	160 Participants n=27 Participants
Primary tumour location Ampullary	19 Participants n=93 Participants	18 Participants n=4 Participants	37 Participants n=27 Participants
Extent of disease Locally advanced	56 Participants n=93 Participants	65 Participants n=4 Participants	121 Participants n=27 Participants
Extent of disease Metastatic	330 Participants n=93 Participants	320 Participants n=4 Participants	650 Participants n=27 Participants
Extent of disease Unknown	2 Participants n=93 Participants	0 Participants n=4 Participants	2 Participants n=27 Participants
Measurable disease Yes	367 Participants n=93 Participants	366 Participants n=4 Participants	733 Participants n=27 Participants
Measurable disease No	21 Participants n=93 Participants	19 Participants n=4 Participants	40 Participants n=27 Participants
ECOG performance status 0	205 Participants n=93 Participants	186 Participants n=4 Participants	391 Participants n=27 Participants
ECOG performance status 1	178 Participants n=93 Participants	192 Participants n=4 Participants	370 Participants n=27 Participants
ECOG performance status Unknown	5 Participants n=93 Participants	7 Participants n=4 Participants	12 Participants n=27 Participants

PRIMARY outcome

Timeframe: Evaluated at Screening (baseline) then every 9 weeks from treatment start (C1D1), or every 12 weeks if treatment is stopped with no evidence of progression, until disease progression or death from any cause up to the end of study, an average of 6 months.

Population: Intent-to-treat with measurable disease at baseline randomized ≥28 weeks before the data cut-off (ITTMD28)

Percentage of patients achieving a confirmed complete response (CR) or partial response (PR) to treatment as assessed by blinded independent review according to RECIST v1.1 criteria. ORR = patients with CR + patients with PR, where" CR = disappearance of all target lesions PR = at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of diameters This outcome was assessed in the population of patients with measurable disease at baseline who were also randomized ≥28 weeks before the data cut-off (ITTMD28). Patients were to receive a confirmatory scan 28-42 days after response is first observed.

Outcome measures

Measure	A - NUC-1031 and Cisplatin n=284 Participants 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	B - Gemcitabine and Cisplatin n=275 Participants 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
Objective Response Rate (ORR)	53 Participants	34 Participants

PRIMARY outcome

Timeframe: From the date of randomization until the date of death from any cause, assessed up to 12 months on average

Population: Intent-to-treat

The median time, in months, from the date of randomization to the date of death from any cause. For patients who were alive at the time of a data cut-off or were permanently lost to follow up, duration of OS was censored at the date at which they were last known to be alive.

Outcome measures

Measure	A - NUC-1031 and Cisplatin n=388 Participants 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	B - Gemcitabine and Cisplatin n=385 Participants 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
Overall Survival (OS)	9.2 Months Interval 8.3 to 10.4	12.6 Months Interval 11.0 to 15.1

Adverse Events

A - NUC-1031 and Cisplatin

Serious events: 175 serious events

Other events: 370 other events

Deaths: 188 deaths

B - Gemcitabine and Cisplatin

Serious events: 126 serious events

Other events: 369 other events

Deaths: 135 deaths

Serious adverse events

Measure	A - NUC-1031 and Cisplatin n=383 participants at risk 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	B - Gemcitabine and Cisplatin n=378 participants at risk 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
Infections and infestations Sepsis	3.1% 12/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	3.2% 12/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations pneumonia	1.3% 5/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.3% 5/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Biliary sepsis	1.3% 5/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.79% 3/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Biliary tract infection	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.3% 5/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations COVID-19	1.0% 4/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.1% 4/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Urinary tract infection	1.0% 4/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.79% 3/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Bacteraemia	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Peritonitis bacterial	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Pseudomonal sepsis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations COVID-19 pneumonia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Device related infection	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Diverticulitis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Liver abscess	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Lower respiratory tract infection	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Neutropenic sepsis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Peritonitis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Spontaneous bacterial peritonitis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Urosepsis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Abdominal abscess	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Abdominal infection	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Appendicitis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Bacillus bacteraemia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Bacterial sepsis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Cellulitis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Clostridium bacteraemia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Clostridium difficile infection	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Device related bacteraemia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Device related sepsis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Enterococcal sepsis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Epiglottitis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Gallbladder abscess	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Hepatitis B reactivation	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Infection	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Klebsiella sepsis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Peritonsillar abscess	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Pneumonia fungal	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Post procedural infection	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Pyelonephritis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Pyelonephritis acute	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Respiratory tract infection	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Septic shock	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Subdiaphragmatic abscess	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Suspected COVID-19	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Upper respiratory tract infection	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations Vascular device infection	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Pyrexia	3.1% 12/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	4.8% 18/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Asthenia	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.79% 3/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Fatigue	1.3% 5/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders General physical health deterioration	1.0% 4/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Oedema peripheral	1.0% 4/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Death (unknown cause)	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Generalised oedema	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Gait disturbance	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Multiple organ dysfunction syndrome	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Non-cardiac chest pain	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Discomfort	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Malaise	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Mucosal inflammation	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Pain	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Vomiting	1.3% 5/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	2.4% 9/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Ascites	1.8% 7/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.1% 4/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Abdominal pain	1.3% 5/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.79% 3/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Nausea	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.79% 3/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Subileus	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Constipation	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Duodenal stenosis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Small intestinal obstruction	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Abdominal distension	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Abdominal rigidity	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Colitis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Colitis ulcerative	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Diarrhoea	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Enterocolitis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Ileus	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Jejunal ulcer	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Large intestine perforation	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Pancreatitis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Cholangitis	2.1% 8/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.1% 4/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Biliary obstruction	1.3% 5/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Jaundice cholestatic	1.0% 4/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hepatic failure	1.3% 5/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hyperbilirubinaemia	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Cholangitis acute	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Drug-induced liver injury	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hepatic function abnormal	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Jaundice	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Gallbladder rupture	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Liver injury	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Cholangitis sclerosing	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Cholecystitis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Cholelithiasis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Cholestasis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Gallbladder obstruction	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hepatic vein embolism	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hepatorenal failure	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hepatotoxicity	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hypertransaminasaemia	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Portal vein embolism	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	3.1% 12/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.9% 7/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Blood bilirubin increased	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.3% 5/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Platelet count decreased	1.0% 4/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Alanine aminotransferase increased	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Aspartate aminotransferase increased	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Blood creatinine increased	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Transaminases increased	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Electrocardiogram QT prolonged	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Hepatic enzyme increased	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Liver function test increased	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Neutrophil count decreased	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations SARS-CoV-2 test positive	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Thrombocytopenia	2.1% 8/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Anaemia	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.3% 5/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Febrile neutropenia	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Neutropenia	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Cytopenia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Lymphadenitis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Pancytopenia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Splenic infarction	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Thrombotic microangiopathy	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Deep vein thrombosis	1.8% 7/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Embolism	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Embolism arterial	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Hypotension	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Arterial thrombosis	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Hypertension	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Orthostatic hypotension	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Shock	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hyponatraemia	1.0% 4/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Dehydration	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hyperglycaemia	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Malnutrition	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Electrolyte imbalance	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hypophagia	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Lactic acidosis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Steroid diabetes	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Cerebrovascular accident	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Ischaemic stroke	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	1.1% 4/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Hepatic encephalopathy	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Cerebral ischaemia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Encephalopathy	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Epilepsy	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Loss of consciousness	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Seizure	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Syncope	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Cardiac arrest	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Acute myocardial infarction	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Cardiac failure	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Angina pectoris	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Arrhythmia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Atrial fibrillation	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Atrial flutter	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Myocardial infarction	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Nodal arrhythmia	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Supraventricular tachycardia	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Tachyarrhythmia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Cardiac disorders Tachycardia	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Hip fracture	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Infusion related reaction	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Spinal compression fracture	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Fall	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Multiple injuries	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Peripancreatic fluid collection	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Spinal fracture	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Subdural haematoma	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Vascular access site thrombosis	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Renal and urinary disorders Acute kidney injury	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Renal and urinary disorders Chronic kidney disease	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Renal and urinary disorders Urinary retention	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Musculoskeletal and connective tissue disorders Back pain	0.78% 3/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Musculoskeletal and connective tissue disorders Muscle fatigue	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Musculoskeletal and connective tissue disorders Muscular weakness	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Product Issues Device occlusion	0.52% 2/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Psychiatric disorders Mental status changes	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Psychiatric disorders Personality change	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Ear and labyrinth disorders Tinnitus	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Endocrine disorders Hypercalcaemia of malignancy	0.26% 1/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.00% 0/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Reproductive system and breast disorders Pelvic pain	0.00% 0/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.26% 1/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.

Other adverse events

Measure	A - NUC-1031 and Cisplatin n=383 participants at risk 725 mg/m\^2 NUC-1031 administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle NUC-1031: IV infusion in 500 mL of 0.9% sterile saline for injection given over 30 minutes Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol	B - Gemcitabine and Cisplatin n=378 participants at risk 1000 mg/m\^2 gemcitabine administered in combination with 25 mg/m\^2 cisplatin on Days 1 and 8 of a 21-day cycle Gemcitabine: IV infusion in 250 mL of 0.9% sterile saline for injection given in accordance with the package insert Cisplatin: IV in accordance with local institutional practice for biliary tract cancer, including the use of an appropriate hydration protocol
Gastrointestinal disorders Nausea	43.6% 167/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	37.6% 142/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Alanine aminotransferase increased	37.1% 142/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	16.4% 62/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Fatigue	36.3% 139/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	30.2% 114/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Aspartate aminotransferase increased	31.6% 121/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	15.1% 57/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Constipation	27.4% 105/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	27.0% 102/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Anaemia	25.8% 99/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	48.4% 183/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Neutropenia	23.0% 88/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	35.2% 133/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Vomiting	21.1% 81/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	17.2% 65/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Thrombocytopenia	19.8% 76/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	19.6% 74/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Platelet count decreased	17.5% 67/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	16.7% 63/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Blood bilirubin increased	17.2% 66/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	4.5% 17/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Asthenia	16.7% 64/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	16.7% 63/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Edema peripheral	15.9% 61/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	13.8% 52/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hypomagnesemia	16.7% 64/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	15.6% 59/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Decreased appetite	15.4% 59/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	14.6% 55/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Abdominal pain	13.8% 53/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	13.8% 52/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Neutrophil count decreased	14.9% 57/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	22.0% 83/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
General disorders Pyrexia	9.7% 37/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	11.9% 45/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Diarrhea	12.5% 48/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	14.8% 56/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Musculoskeletal and connective tissue disorders Back pain	10.2% 39/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	7.1% 27/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Ascites	8.4% 32/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	3.4% 13/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hypoalbuminemia	10.2% 39/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	5.8% 22/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Blood and lymphatic system disorders Leukopenia	6.0% 23/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	10.6% 40/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Abdominal pain upper	5.0% 19/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	9.5% 36/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Dyspepsia	5.5% 21/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	5.3% 20/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Gastrointestinal disorders Abdominal distension	5.7% 22/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	3.7% 14/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations Blood alkaline phosphatase increased	9.4% 36/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	6.9% 26/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Investigations White blood cell count decreased	6.5% 25/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	8.7% 33/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Weight decreased	5.2% 20/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	6.6% 25/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Blood creatinine increased	2.3% 9/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	6.3% 24/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hypokalaemia	7.0% 27/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	5.6% 21/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Metabolism and nutrition disorders Hyperglycemia	5.7% 22/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	5.3% 20/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Infections and infestations COVID-19	5.2% 20/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	4.5% 17/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Dizziness	9.7% 37/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	7.1% 27/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Headache	7.8% 30/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	7.7% 29/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Dysgeusia	6.5% 25/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	6.3% 24/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Nervous system disorders Neuropathy peripheral	2.3% 9/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	6.3% 24/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Respiratory, thoracic and mediastinal disorders Dyspnea	8.9% 34/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	8.5% 32/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Skin and subcutaneous tissue disorders Alopecia	5.7% 22/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	6.9% 26/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Hypertension	5.0% 19/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	6.9% 26/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Vascular disorders Deep vein thrombosis	4.7% 18/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	3.4% 13/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Hepatobiliary disorders Hyperbilirubinemia	8.1% 31/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	2.1% 8/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Psychiatric disorders Insomnia	5.0% 19/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	8.5% 32/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.
Injury, poisoning and procedural complications Infusion related reaction	5.0% 19/383 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.	0.53% 2/378 • Each patient was assessed for serious and other (non-serious) adverse events from the date of consent until 30 days after the last dose of study treatment, an average of 6 months. Each patient was assessed for all-cause mortality from the date of randomization until the date of death from any cause, an average of 12 months All adverse events are reported for the Safety Population, which consisted of all patients in the ITT population who also received any study medication. This differs from all-cause mortality, which is reported for the ITT population.

Additional Information

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