Trial Outcomes & Findings for Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002) (NCT NCT03094832)

Last Updated: 2023-04-13

Results Overview

An AE was defined as any untoward medical occurrence associated with the use of a drug in a participant, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a medicinal product and does not imply any judgment about causality.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Up to approximately 48 months

Results posted on

2023-04-13

Participant Flow

50 participants were enrolled in the study of which 49 participants received at least one dose of treatment and was used for safety analysis.

Participant milestones

Participant milestones
Measure	Part A: Miransertib PROS/PS During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS (Cohort 1) During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PS (Cohort 2) During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS/PS (Cohort 3) During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2).
Overall Study STARTED	17	22	1	8	2
Overall Study Treated	17	22	1	8	1
Overall Study COMPLETED	2	2	0	0	0
Overall Study NOT COMPLETED	15	20	1	8	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Part A: Miransertib PROS/PS During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS (Cohort 1) During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PS (Cohort 2) During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS/PS (Cohort 3) During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2).
Overall Study Lost to Follow-up	0	0	0	1	1
Overall Study Death	1	0	0	0	0
Overall Study Withdrawal by Parent/Guardian	1	0	0	0	0
Overall Study Other	13	20	1	7	1

Baseline Characteristics

Study of Miransertib (MK-7075) in Participants With PIK3CA-related Overgrowth Spectrum and Proteus Syndrome (MOSAIC) (MK-7075-002)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Part A: Miransertib PROS/PS n=17 Participants During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS (Cohort 1) n=22 Participants During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PS (Cohort 2) n=1 Participants During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS/PS (Cohort 3) n=8 Participants During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) n=2 Participants During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2).	Total n=50 Participants Total of all reporting groups
Age, Continuous	8.2 years STANDARD_DEVIATION 9.9 • n=5 Participants	9.9 years STANDARD_DEVIATION 6.7 • n=7 Participants	12.0 years STANDARD_DEVIATION NA • n=5 Participants	12.5 years STANDARD_DEVIATION 9.1 • n=4 Participants	20.0 years STANDARD_DEVIATION 1.4 • n=21 Participants	10.2 years STANDARD_DEVIATION 8.3 • n=10 Participants
Sex: Female, Male Female	9 Participants n=5 Participants	10 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	23 Participants n=10 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	12 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	1 Participants n=21 Participants	27 Participants n=10 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	3 Participants n=10 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	20 Participants n=7 Participants	1 Participants n=5 Participants	8 Participants n=4 Participants	2 Participants n=21 Participants	46 Participants n=10 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	4 Participants n=10 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	5 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	6 Participants n=10 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	13 Participants n=7 Participants	1 Participants n=5 Participants	6 Participants n=4 Participants	2 Participants n=21 Participants	39 Participants n=10 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=10 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=10 Participants

PRIMARY outcome

Timeframe: Up to approximately 48 months

Population: All participants who have received at least one dose of study treatment were analyzed.

Outcome measures

Outcome measures
Measure	Part A: Miransertib PROS/PS n=17 Participants During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS (Cohort 1) n=22 Participants During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PS (Cohort 2) n=1 Participants During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS/PS (Cohort 3) n=8 Participants During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) n=1 Participants During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2).
Number of Participants Who Experienced an Adverse Event (AE)	17 Participants	20 Participants	0 Participants	6 Participants	1 Participants

PRIMARY outcome

Timeframe: Up to approximately 45 months

Population: All participants who have received at least one dose of study treatment were analyzed.

Outcome measures

Outcome measures
Measure	Part A: Miransertib PROS/PS n=17 Participants During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS (Cohort 1) n=22 Participants During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PS (Cohort 2) n=1 Participants During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS/PS (Cohort 3) n=8 Participants During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B:Miransertib Compassionate Use/Expanded Access(Cohort 4) n=1 Participants During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2).
Number of Participants Who Discontinued Study Treatment Due to an AE	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants

Adverse Events

Part A: Miransertib PROS/PS

Serious events: 4 serious events

Other events: 17 other events

Deaths: 1 deaths

Part B: Miransertib PROS (Cohort 1)

Serious events: 3 serious events

Other events: 18 other events

Deaths: 0 deaths

Part B: Miransertib PS (Cohort 2)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Part B: Miransertib PROS/PS (Cohort 3)

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Part A: Miransertib PROS/PS n=17 participants at risk During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS (Cohort 1) n=22 participants at risk During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PS (Cohort 2) n=1 participants at risk During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS/PS (Cohort 3) n=8 participants at risk During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4) n=1 participants at risk During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2).
Blood and lymphatic system disorders Anaemia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Nausea	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Vomiting	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Cellulitis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Febrile convulsion	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.

Other adverse events

Other adverse events
Measure	Part A: Miransertib PROS/PS n=17 participants at risk During Cycles 1-3, participants with either PROS (phosphatidylinositol- 4,5-bisphosphate 3-kinase, catalytic subunit alpha \[PIK3CA\]-related Overgrowth Spectrum) or PS (Proteus syndrome) received miransertib 15 mg/m\^2 once daily (QD) (each cycle length = 28 days). From Cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 and then titrated to 35 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS (Cohort 1) n=22 participants at risk During Cycles 1-3, participants with PROS who have a measurable lesion by volumetric magnetic resonance imaging (MRI) received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PS (Cohort 2) n=1 participants at risk During Cycles 1-3, participants with PS who have a measurable lesion by standardized digital photography received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib PROS/PS (Cohort 3) n=8 participants at risk During Cycles 1-3, participants with PROS or PS who do not meet all the eligibility criteria for Cohorts 1 or 2 received miransertib 15 mg/m\^2 QD (each cycle length = 28 days). From cycles 4-48 or until disease progression, unacceptable toxicity, or discontinuation, participants received miransertib dose titrated to 25 mg/m\^2 orally QD at the investigator's discretion.	Part B: Miransertib Compassionate Use/Expanded Access (Cohort 4) n=1 participants at risk During cycles 1-48 (each cycle length = 28 days) or until disease progression, unacceptable toxicity, or discontinuation, participants previously treated with miransertib or currently receiving miransertib under Compassionate Use/Expanded Access continued to receive the current dose of miransertib (did not exceed 25 mg/m\^2).
Investigations Fibrin D dimer increased	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Haematocrit increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Skin lesion	17.6% 3/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Haemoglobin increased	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Low density lipoprotein increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Blood and lymphatic system disorders Anaemia	11.8% 2/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Blood and lymphatic system disorders Eosinophilia	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Blood and lymphatic system disorders Immune thrombocytopenia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Blood and lymphatic system disorders Neutropenia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Blood and lymphatic system disorders Thrombocytopenia	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Cardiac disorders Palpitations	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Cardiac disorders Sinus bradycardia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Cardiac disorders Sinus tachycardia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Cardiac disorders Tachycardia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Congenital, familial and genetic disorders Phimosis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Congenital, familial and genetic disorders Vascular malformation	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Ear and labyrinth disorders Ear pain	11.8% 2/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Ear and labyrinth disorders Excessive cerumen production	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Ear and labyrinth disorders Vertigo	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Eye disorders Conjunctival hyperaemia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Eye disorders Erythema of eyelid	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Eye disorders Eye discharge	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Eye disorders Eyelid oedema	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Abdominal pain	41.2% 7/17 • Number of events 11 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	50.0% 4/8 • Number of events 7 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Abdominal pain upper	17.6% 3/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Aphthous ulcer	23.5% 4/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Cheilitis	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Constipation	35.3% 6/17 • Number of events 20 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	37.5% 3/8 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Dental caries	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Diarrhoea	47.1% 8/17 • Number of events 12 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	50.0% 4/8 • Number of events 10 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Dry mouth	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Food poisoning	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Frequent bowel movements	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Haematochezia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Mouth haemorrhage	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Nausea	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	18.2% 4/22 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	37.5% 3/8 • Number of events 7 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Oral pain	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	13.6% 3/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Rectal haemorrhage	5.9% 1/17 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Salivary duct obstruction	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Stomatitis	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	18.2% 4/22 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Swollen tongue	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Toothache	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Gastrointestinal disorders Vomiting	64.7% 11/17 • Number of events 24 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	22.7% 5/22 • Number of events 13 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Asthenia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Chest pain	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Chills	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Face oedema	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Fatigue	11.8% 2/17 • Number of events 7 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	13.6% 3/22 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Inflammation	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Influenza like illness	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Lithiasis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Localised oedema	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Mucosal inflammation	17.6% 3/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Non-cardiac chest pain	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Oedema peripheral	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Pain	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Pyrexia	88.2% 15/17 • Number of events 74 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	13.6% 3/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Suprapubic pain	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Swelling	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
General disorders Thirst	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Hepatobiliary disorders Hypertransaminasaemia	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations COVID-19	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Cellulitis	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	18.2% 4/22 • Number of events 10 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Conjunctivitis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Coxsackie viral infection	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Cystitis	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Eye infection	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Fungal skin infection	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Gastroenteritis	23.5% 4/17 • Number of events 8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Impetigo	17.6% 3/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Infection	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Influenza	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Laryngitis	5.9% 1/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Nasopharyngitis	17.6% 3/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Otitis media	11.8% 2/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Otitis media acute	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Paronychia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Pharyngitis	29.4% 5/17 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Pharyngotonsillitis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Rhinitis	29.4% 5/17 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Scarlet fever	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Sinusitis	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Soft tissue infection	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Tonsillitis	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Tracheitis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Upper respiratory tract infection	17.6% 3/17 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	31.8% 7/22 • Number of events 13 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Urinary tract infection	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Viraemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Infections and infestations Viral infection	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Injury, poisoning and procedural complications Contusion	5.9% 1/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Injury, poisoning and procedural complications Fall	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Injury, poisoning and procedural complications Head injury	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Injury, poisoning and procedural complications Injury	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Injury, poisoning and procedural complications Limb injury	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Injury, poisoning and procedural complications Scratch	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Injury, poisoning and procedural complications Wound dehiscence	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Activated partial thromboplastin time prolonged	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Alanine aminotransferase increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Anion gap	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Aspartate aminotransferase increased	11.8% 2/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Blood bicarbonate decreased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Blood cholesterol increased	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Blood fibrinogen increased	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Blood insulin increased	11.8% 2/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Blood lactate dehydrogenase increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	50.0% 4/8 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Bone density decreased	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations C-reactive protein increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Electrocardiogram QT prolonged	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Fibrin D dimer decreased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Lymphocyte count decreased	11.8% 2/17 • Number of events 8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	50.0% 4/8 • Number of events 10 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Lymphocyte count increased	5.9% 1/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Monocyte count decreased	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Neutrophil count decreased	23.5% 4/17 • Number of events 17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	37.5% 3/8 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Neutrophil count increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Platelet count decreased	17.6% 3/17 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Platelet count increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations SARS-CoV-2 test positive	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Urine ketone body present	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations Weight decreased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations White blood cell count decreased	11.8% 2/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Investigations White blood cell count increased	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Alkalosis	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Decreased appetite	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	13.6% 3/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Dehydration	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hyperinsulinaemia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hyperkalaemia	11.8% 2/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hyponatraemia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Metabolism and nutrition disorders Vitamin D deficiency	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Arthralgia	23.5% 4/17 • Number of events 14 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	37.5% 3/8 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Bone pain	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Osteochondrosis	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	29.4% 5/17 • Number of events 27 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	37.5% 3/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Scoliosis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Musculoskeletal and connective tissue disorders Spinal pain	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Haemangioma	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Dizziness	5.9% 1/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	13.6% 3/22 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	37.5% 3/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Headache	17.6% 3/17 • Number of events 9 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Skin mass	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Paraesthesia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Petit mal epilepsy	5.9% 1/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Presyncope	11.8% 2/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Sciatica	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Nervous system disorders Syncope	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Psychiatric disorders Anxiety	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Psychiatric disorders Delirium	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Psychiatric disorders Enuresis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Renal and urinary disorders Haematuria	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Renal and urinary disorders Proteinuria	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Renal and urinary disorders Renal disorder	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Renal and urinary disorders Urinary retention	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Reproductive system and breast disorders Oedema genital	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Reproductive system and breast disorders Perineal erythema	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Reproductive system and breast disorders Perineal pain	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Reproductive system and breast disorders Testicular oedema	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Reproductive system and breast disorders Vaginal haemorrhage	5.9% 1/17 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Reproductive system and breast disorders Vulvovaginal pain	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Bradypnoea	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Cough	58.8% 10/17 • Number of events 17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	13.6% 3/22 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	37.5% 3/8 • Number of events 7 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Hiccups	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	5.9% 1/17 • Number of events 6 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	13.6% 3/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Nasal obstruction	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	17.6% 3/17 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Pharyngeal erythema	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Tonsillolith	5.9% 1/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Respiratory, thoracic and mediastinal disorders Upper respiratory tract inflammation	11.8% 2/17 • Number of events 5 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Alopecia	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Blister	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Bullous haemorrhagic dermatosis	5.9% 1/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Dermatitis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Dry skin	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Eczema	11.8% 2/17 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Perioral dermatitis	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Petechiae	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	25.0% 2/8 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Pityriasis rosea	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Rash	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	9.1% 2/22 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	29.4% 5/17 • Number of events 7 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Skin disorder	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Skin hypopigmentation	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Skin irritation	11.8% 2/17 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Skin and subcutaneous tissue disorders Skin ulcer	5.9% 1/17 • Number of events 3 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Vascular disorders Deep vein thrombosis	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/8 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	100.0% 1/1 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Vascular disorders Hypertension	5.9% 1/17 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 4 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Vascular disorders Hypotension	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Vascular disorders Lymphorrhoea	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	4.5% 1/22 • Number of events 2 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.
Vascular disorders Venous haemorrhage	0.00% 0/17 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/22 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	12.5% 1/8 • Number of events 1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.	0.00% 0/1 • Up to approximately 48 months All-cause mortality was reported on all enrolled participants. Non-serious and serious AEs were reported on all participants who received at least one dose of study treatment. Per protocol, disease progression (DP) was not considered an AE unless related to treatment.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The investigator shall have the right to publish the results performed under this protocol, provided that such publication does not disclose any Confidential Information or trade secrets of the Sponsor (other than the data). The investigator agrees not to independently publish the findings except as part of an overall multicenter publication, unless approved in writing by the Sponsor or unless more than 12 months have elapsed since the last participant in the study has completed study treatment.
Publication restrictions are in place

Restriction type: OTHER