Trial Outcomes & Findings for A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer (NCT NCT02291055)

NCT ID: NCT02291055

Last Updated: 2023-03-20

Results Overview

An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. Any worsening (ie, any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also considered an AE. A serious adverse event (SAE) was any AE that: results in death; life threatening; resulted in or prolonged an existing inpatient hospitalization, persistent or significant disability/incapacity; congenital anomaly; a new cancer; associated with an overdose; another important medical event. Treatment emergent was defined as events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 75 participants
• Primary outcome timeframe: From first dose until 30 days after last dose (maximum duration: 98 weeks)
• Results posted on: 2023-03-20

Participant Flow

Participants were enrolled at study centers in the United States.

Participants with a diagnosis of cervical cancer and human papillomavirus (HPV) positive squamous cell carcinoma of head and neck (SCCHN) were enrolled in the study.

Participant milestones

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Overall Study STARTED	5	5	11	27	27
Overall Study COMPLETED	0	0	3	0	0
Overall Study NOT COMPLETED	5	5	8	27	27

Reasons for withdrawal

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Overall Study Death	2	2	5	8	12
Overall Study Lost to Follow-up	0	0	0	1	2
Overall Study Withdrawal by Subject	3	1	1	5	10
Overall Study Progressive Disease	0	0	1	4	2
Overall Study Study Terminated by Sponsor	0	0	0	5	1
Overall Study Other	0	2	1	4	0

Baseline Characteristics

A Study of ADXS11-001 or MEDI4736 Alone or Combination In Cervical or Human Papillomavirus (HPV)+ Head & Neck Cancer

Baseline characteristics by cohort

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=5 Participants Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=5 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=11 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 n=27 Participants Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=27 Participants Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Total n=75 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	23 Participants n=4 Participants	27 Participants n=21 Participants	68 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	0 Participants n=21 Participants	7 Participants n=8 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	0 Participants n=5 Participants	27 Participants n=4 Participants	27 Participants n=21 Participants	63 Participants n=8 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	1 Participants n=7 Participants	11 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	12 Participants n=8 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	12 Participants n=8 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants	24 Participants n=4 Participants	21 Participants n=21 Participants	63 Participants n=8 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	2 Participants n=8 Participants
Race/Ethnicity, Customized Race · Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	3 Participants n=21 Participants	10 Participants n=8 Participants
Race/Ethnicity, Customized Race · White	3 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants	19 Participants n=4 Participants	21 Participants n=21 Participants	57 Participants n=8 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	2 Participants n=21 Participants	6 Participants n=8 Participants

PRIMARY outcome

Timeframe: From first dose until 30 days after last dose (maximum duration: 98 weeks)

Population: All Treated Population.

An adverse event (AE) was any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have a causal relationship with this treatment. Any worsening (ie, any clinically significant adverse change in frequency and/or intensity) of a preexisting condition that was temporally associated with the use of the Sponsor's product, was also considered an AE. A serious adverse event (SAE) was any AE that: results in death; life threatening; resulted in or prolonged an existing inpatient hospitalization, persistent or significant disability/incapacity; congenital anomaly; a new cancer; associated with an overdose; another important medical event. Treatment emergent was defined as events with onset dates on or after the first dose of study medication and within 30 days following the last dose of study medication.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=5 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=5 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=11 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 n=27 Participants Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=27 Participants Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part A and Part B TEAEs	5 participants	5 participants	11 participants	25 participants	27 participants
Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs) in Part A and Part B TESAEs	2 participants	3 participants	4 participants	13 participants	15 participants

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: The objective response rate (ORR) evaluable with cervical cancer population included all participants in the All Treated Population who had cervical cancer and had at least 1 post-baseline radiologic tumor response assessment (complete response \[CR\], partial response \[PR\], stable disease \[SD\], or progressive disease \[PD\]).

Progression-free survival (PFS) was defined as the time from randomization until objective tumor progression based on response evaluation criteria in solid tumors (RECIST) version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=4 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=23 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=20 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Progression Free Survival (Part A and Part B): Cervical Cancer Population	3.7 months Interval 1.8 to 22.1	2.1 months Interval 1.7 to 3.8	5.0 months Interval 1.8 to 6.9	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: The ORR Evaluable with HPV+ head and neck cancer population included all participants in the All Treated Population who had HPV+ head and neck cancer and had at least 1 post-baseline radiologic tumor response assessment (CR, PR, SD, or PD).

PFS was defined as the time from randomization until objective tumor progression based on RECIST version 1.1 or death. The progressive disease is defined at least a 20% increase in the sum of the longest diameter of target lesions, taking as reference the smallest sum longest diameter recorded since the treatment started, the appearance of one or more new lesions, or unequivocal progression of existing non-target lesions. Participants who had not experienced disease progression or who were still alive at the time of evaluation were censored for the analysis. The PFS was estimated using Kaplan-Meier method.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=12 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Progression Free Survival (Part A): Human Papillomavirus (HPV)+ Head and Neck Cancer Population	3.5 months Interval 1.6 to 5.3	—	—	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with Cervical Cancer Population.

The objective response is defined as confirmed complete response (CR) or partial response (PR) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 millimeter (mm). The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=4 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=23 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=20 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population	25.0 percentage of participants Interval 0.6 to 80.6	8.7 percentage of participants Interval 1.1 to 28.0	10.0 percentage of participants Interval 1.2 to 31.7	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with HPV+ Head and Neck Cancer Population

The objective response is defined as confirmed CR or PR based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=12 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Objective Response as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population	0.00 percentage of participants Interval 0.0 to 0.0	—	—	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with Cervical Cancer Population.

The objective response is defined as confirmed CR or confirmed PR based on immune-related RECIST (irRECIST) v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=4 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=23 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=20 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population	25.0 percentage of participants Interval 0.6 to 80.6	8.7 percentage of participants Interval 1.1 to 28.0	10.0 percentage of participants Interval 1.2 to 31.7	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with HPV+ Head and Neck Cancer Population.

The objective response is defined as confirmed CR or confirmed PR based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=12 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Objective Response as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population	0.00 percentage of participants Interval 0.0 to 0.0	—	—	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with Cervical Cancer Population.

The DCR is defined percentage of participants with CR, PR, or stable disease (SD) based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=4 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=23 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=20 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A and Part B): Cervical Cancer Population	50.0 percentage of participants Interval 6.8 to 93.2	47.8 percentage of participants Interval 26.8 to 69.4	65.0 percentage of participants Interval 40.8 to 84.6	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with HPV+ Head and Neck Cancer Population.

The DCR is defined percentage of participants with CR, PR, or SD based on RECIST v1.1 guidelines. The CR is defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. The PR is defined as >= 30% decrease in the sum of the longest diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum longest diameter since the study treatment started. The PD is defined as at least 20% increase in sum of diameters of target lesions, taking as reference the smallest sum on study. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=12 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Disease Control as Per RECIST Criteria (Part A): HPV+ Head and Neck Cancer Population	58.3 percentage of participants Interval 27.7 to 84.8	—	—	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with Cervical Cancer Population.

The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=4 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=23 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=20 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A and Part B): Cervical Cancer Population	75.0 percentage of participants Interval 19.4 to 99.4	52.2 percentage of participants Interval 30.6 to 73.2	65.0 percentage of participants Interval 40.8 to 84.6	—	—

PRIMARY outcome

Timeframe: From randomization until objective tumor progression or death (maximum duration: 146 weeks)

Population: ORR Evaluable with HPV+ Head and Neck Cancer Population.

The DCR is defined percentage of participants with irCR, irPR, or irSD based on irRECIST v1.1 guidelines. The irCR is defined as disappearance of all target and non-target lesions, no new lesions, and normalization of tumor marker level. The irPR is defined as >= 30% decrease in tumor burden compared with baseline. The irSD is defined as neither a 30% decrease in tumor burden compared with baseline nor a 20% increase compared with nadir can be established.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=12 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Percentage of Participants With Disease Control as Per irRECIST Criteria (Part A): HPV+ Head and Neck Cancer Population	50.0 percentage of participants Interval 21.1 to 78.9	—	—	—	—

PRIMARY outcome

Timeframe: From first dose until death (maximum duration: 146 weeks)

Population: All Treated Population.

Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=5 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=30 Participants Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=27 Participants Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Overall Survival: Cervical Cancer Population	NA months Interval 2.8 to Median, and upper limits of 95% CI were not estimable as more than 50% of participants were censored.	9.3 months Interval 6.0 to Upper limits of 95% CI were not estimable as more than 50% of participants were censored.	9.2 months Interval 6.9 to Upper limits of 95% CI were not estimable as more than 50% of participants were censored.	—	—

PRIMARY outcome

Timeframe: From first dose until death (maximum duration: 146 weeks)

Population: All Treated Population.

Overall survival is defined as the time from the date of start of study treatment until death due to any cause. Any participant not died at the time of analysis was censored based on the last recorded date on which the participant was known to be alive. The OS was estimated using Kaplan-Meier method.

Outcome measures

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=13 Participants Participants with cervical cancer received MEDI4736 3 milligrams per kilogram (mg/kg) intravenous (IV) infusion every 2 weeks (Q2W) at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion every 4 weeks (Q4W) at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Overall Survival: HPV+ Head and Neck Cancer Population	4.8 months Interval 3.6 to Upper limits of 95% CI were not estimable as more than 50% of participants were censored.	—	—	—	—

Adverse Events

Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736

Serious events: 2 serious events

Other events: 5 other events

Deaths: 2 deaths

Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736

Serious events: 3 serious events

Other events: 5 other events

Deaths: 2 deaths

Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736

Serious events: 4 serious events

Other events: 11 other events

Deaths: 7 deaths

Part B Expansion (Cervical): 10 mg/kg MEDI4736

Serious events: 13 serious events

Other events: 25 other events

Deaths: 8 deaths

Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736

Serious events: 15 serious events

Other events: 27 other events

Deaths: 12 deaths

Serious adverse events

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=5 participants at risk Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=5 participants at risk Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=11 participants at risk Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 n=27 participants at risk Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=27 participants at risk Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Cardiac disorders Cardiac arrest	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Blood and lymphatic system disorders Anaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Abdominal pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Colonic fistula	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Constipation	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Diarrhoea	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Large intestine perforation	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Nausea	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Small intestine obstruction	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Vomiting	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Asthenia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Chest pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Disease progression	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Fatigue	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Performance status decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Abdominal abscess	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Clostridium difficile infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Pneumonia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Sepsis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Septic shock	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Upper respiratory track infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Urinary tract infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Upper limb fracture	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Urinary tract stoma complication	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis to central nervous system	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Confusional state	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Mental status changes	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Acute kidney injury	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Haematuria	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Hydronephrosis	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Pelvic pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Deep vein thrombosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Embolism	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Hypotension	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.

Other adverse events

Measure	Part A Escalation (Cervical): 1×10^9 CFU ADXS11-001/ 3 mg/kg MEDI4736 n=5 participants at risk Participants with cervical cancer received MEDI4736 3 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Escalation (Cervical and Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=5 participants at risk Participants with cervical cancer and SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part A Expansion (Head and Neck): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=11 participants at risk Participants with SCCHN received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 10 mg/kg MEDI4736 n=27 participants at risk Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.	Part B Expansion (Cervical): 1×10^9 CFU ADXS11-001/ 10 mg/kg MEDI4736 n=27 participants at risk Participants with cervical cancer received MEDI4736 10 mg/kg IV infusion Q2W at an infusion rate of approximately 60 minutes followed by ADXS11-001 1×10\^9 CFU IV infusion Q4W at an infusion rate of approximately 60 minutes. Treatment cycles were 8-week in duration and participants were to continue therapy for up to 1 year or until documented progression, unacceptable toxicity, withdrawal of consent, or other treatment discontinuation criteria were met.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	37.0% 10/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Blood and lymphatic system disorders Anaemia	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	27.3% 3/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	37.0% 10/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	29.6% 8/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Blood and lymphatic system disorders Iron deficiency anaemia	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Cardiac disorders Angina pectoris	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Cardiac disorders Bradycardia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Cardiac disorders Cardiac arrest	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Cardiac disorders Sinus tachycardia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Cardiac disorders Tachycardia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	27.3% 3/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	29.6% 8/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Ear and labyrinth disorders Motion sickness	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Ear and labyrinth disorders Vestibular disorder	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Endocrine disorders Hyperthyroidism	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Endocrine disorders Hypothyroidism	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Endocrine disorders Thyroiditis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Eye disorders Lacrimation increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Eye disorders Ocular hyperaemia	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Eye disorders Periorbital oedema	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Eye disorders Vision blurred	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Eye disorders Visual impairment	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Abdominal distension	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Abdominal pain	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.5% 5/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Ascites	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Breath odour	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Colonic fistula	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Constipation	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	27.3% 3/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.5% 5/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	44.4% 12/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Dry mouth	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Dyspepsia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Dysphagia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Flatulence	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Gastrooesophageal reflux disease	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Glossodynia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Haematochezia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Hypoaesthesia oral	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Large intestine perforation	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Levator syndrome	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Lip dry	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Lip swelling	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Nausea	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	60.0% 3/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	27.3% 3/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	44.4% 12/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Oral pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Stomatitis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Swollen tongue	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Tongue discomfort	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Tongue ulceration	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Gastrointestinal disorders Vomiting	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	27.3% 3/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.5% 5/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	40.7% 11/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Asthenia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Catheter site haemorrhage	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Chest discomfort	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Chest pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Chills	80.0% 4/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	100.0% 5/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	66.7% 18/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Disease progression	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Face oedema	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Fatigue	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	45.5% 5/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	29.6% 8/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	44.4% 12/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Influenza like illness	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Malaise	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Non-cardiac chest pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Oedema peripheral	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Performance status decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Peripheral swelling	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
General disorders Pyrexia	60.0% 3/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	60.0% 3/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	27.3% 3/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	48.1% 13/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Immune system disorders Cytokine release syndrome	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	45.5% 5/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	25.9% 7/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Immune system disorders Drug hypersensitivity	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Abdominal abscess	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Abdominal infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Abdominal wall abscess	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Clostridium difficile infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Fungal infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Herpes simplex	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Herpes zoster	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Influenza	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Oral candidiasis	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Oral herpes	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Pneumonia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Sepsis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Septic shock	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Stoma site candida	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Tooth infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Upper respiratory tract infection	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Infections and infestations Urinary tract infection	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.5% 5/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Compression fracture	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Facial bones fracture	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Fall	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Lumbar vertebral fracture	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Post procedural haematuria	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Procedural nausea	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Spinal compression fracture	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Stoma site inflammation	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Upper limb fracture	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Injury, poisoning and procedural complications Urinary tract stoma complication	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Alanine aminotransferase increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Aspartate aminotransferase increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood alkaline phosphatase increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood bilirubin increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood calcium decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood creatine increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood creatinine increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.5% 5/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood glucose increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood lactate dehydrogenase increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood magnesium decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood potassium increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Blood urea increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Heart rate increased	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Lymphocyte count decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Neutrophil count decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Platelet count decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Po2 decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Protein total increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Respiratory rate decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Thyroxine increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Tri-iodothyronine decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Weight decreased	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations Weight increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations White blood cell count decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Investigations White blood cell count increased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Decreased appetite	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	27.3% 3/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	29.6% 8/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Dehydration	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Fluid retention	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypochloraemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	22.2% 6/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	25.9% 7/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Malnutrition	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Metabolism and nutrition disorders Type 1 diabetes mellitus	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Arthralgia	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Muscle spasms	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Muscle tightness	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Myalgia	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Pain in extremity	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Musculoskeletal and connective tissue disorders Spinal column stenosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cervix carcinoma	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to peritoneum	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Amnesia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Dizziness	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Dizziness postural	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Dysgeusia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Headache	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	33.3% 9/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Hypersomnia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Hypoaesthesia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Lethargy	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Paraesthesia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Somnolence	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Nervous system disorders Tremor	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	14.8% 4/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Anxiety	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Confusional state	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Depression	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Euphoric mood	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Insomnia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Mental status changes	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Psychiatric disorders Sleep disorder	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Acute kidney injury	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Bladder pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Chromaturia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Dysuria	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Haematuria	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Hydronephrosis	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Renal tubular necrosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Urine flow decreased	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Renal and urinary disorders Urine odour abnormal	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Breast pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Female genital tract fistula	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Pelvic pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Vulvovaginal pruritus	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Reproductive system and breast disorders Vulvovaginal swelling	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Bronchospasm	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	11.1% 3/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Dry throat	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	18.2% 2/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	22.2% 6/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Skin and subcutaneous tissue disorders Cold sweat	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Skin and subcutaneous tissue disorders Pruritus generalised	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Skin and subcutaneous tissue disorders Rash	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Deep vein thrombosis	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Embolism	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Flushing	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Hypertension	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	7.4% 2/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Hypotension	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	40.0% 2/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	45.5% 5/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	44.4% 12/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Lymphoedema	20.0% 1/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Peripheral coldness	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	9.1% 1/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.
Vascular disorders Varicose vein	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/5 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/11 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	0.00% 0/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.	3.7% 1/27 • All-cause mortality: From randomization until end of study (maximum duration: 146 weeks). Adverse events: From first dose until 30 days after last dose (maximum duration: 98 weeks) All-cause mortality: All participants who were randomized in the study. Adverse events: All Treated Population.

Additional Information

Surya Vangala

Advaxis, Inc.

Phone: 609-423-2528

Email: vangala@advaxis.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Investigator shall seek the Sponsor's written approval for study results publication which shall not be unreasonably withheld. Such publication by Institution and/or Investigator may be no earlier than after a cooperative publication has been published with Sponsor or 1 year from date of completion or termination of the Study \& only after review and comment by Sponsor. Institution agrees to provide Sponsor a copy of proposed publication at least 60 days prior to submission to a publisher.
• Publication restrictions are in place

Restriction type: OTHER