Trial Outcomes & Findings for A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer (NCT NCT04916002)

NCT ID: NCT04916002

Last Updated: 2025-12-05

Results Overview

ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 77 participants
• Primary outcome timeframe: Up to 31.5 Months
• Results posted on: 2025-12-05

Participant Flow

Participant milestones

Measure	Cohort A1: CMP-001+Cemiplimab for CSCC Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule	Cohort A2: CMP-001+Cemiplimab for CSCC Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule
Overall Study STARTED	25	19	13	16	4
Overall Study COMPLETED	0	0	0	0	0
Overall Study NOT COMPLETED	25	19	13	16	4

Reasons for withdrawal

Measure	Cohort A1: CMP-001+Cemiplimab for CSCC Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule	Cohort A2: CMP-001+Cemiplimab for CSCC Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule
Overall Study Adverse Event	0	1	0	1	0
Overall Study Withdrawal by Subject	3	1	0	1	0
Overall Study Death	8	7	4	9	0
Overall Study Study Terminated by Sponsor	11	10	8	5	4
Overall Study End of trial	1	0	0	0	0
Overall Study Progressive disease	0	0	1	0	0
Overall Study Participant non-compliance	2	0	0	0	0

Baseline Characteristics

A Trial To Find Out If Vidutolimod Together With Cemiplimab Is Safe And If It Works In Adult Participants With Advanced Cancer Or Metastatic Cancer

Baseline characteristics by cohort

Measure	Total n=77 Participants Total of all reporting groups	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 Participants Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 Participants Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 Participants Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 Participants Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 Participants Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule
Age, Continuous	68.8 Years STANDARD_DEVIATION 12.46 • n=6 Participants	70.5 Years STANDARD_DEVIATION 14.09 • n=37 Participants	67.9 Years STANDARD_DEVIATION 9.42 • n=37 Participants	71.0 Years STANDARD_DEVIATION 11.55 • n=74 Participants	69.2 Years STANDARD_DEVIATION 13.20 • n=267 Participants	54.5 Years STANDARD_DEVIATION 9.40 • n=272 Participants
Sex: Female, Male Female	23 Participants n=6 Participants	6 Participants n=37 Participants	7 Participants n=37 Participants	5 Participants n=74 Participants	5 Participants n=267 Participants	0 Participants n=272 Participants
Sex: Female, Male Male	54 Participants n=6 Participants	19 Participants n=37 Participants	12 Participants n=37 Participants	8 Participants n=74 Participants	11 Participants n=267 Participants	4 Participants n=272 Participants
Race/Ethnicity, Customized White	68 Participants n=6 Participants	22 Participants n=37 Participants	15 Participants n=37 Participants	12 Participants n=74 Participants	15 Participants n=267 Participants	4 Participants n=272 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=6 Participants	0 Participants n=37 Participants	1 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants
Race/Ethnicity, Customized Asian	1 Participants n=6 Participants	1 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants
Race/Ethnicity, Customized American Indian / Alaskan Native	0 Participants n=6 Participants	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=6 Participants	0 Participants n=37 Participants	0 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants
Race/Ethnicity, Customized Not Reported	1 Participants n=6 Participants	0 Participants n=37 Participants	1 Participants n=37 Participants	0 Participants n=74 Participants	0 Participants n=267 Participants	0 Participants n=272 Participants
Race/Ethnicity, Customized Other	5 Participants n=6 Participants	2 Participants n=37 Participants	2 Participants n=37 Participants	0 Participants n=74 Participants	1 Participants n=267 Participants	0 Participants n=272 Participants
Race/Ethnicity, Customized Hispanic or Latino	6 Participants n=6 Participants	4 Participants n=37 Participants	0 Participants n=37 Participants	1 Participants n=74 Participants	1 Participants n=267 Participants	0 Participants n=272 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	70 Participants n=6 Participants	21 Participants n=37 Participants	18 Participants n=37 Participants	12 Participants n=74 Participants	15 Participants n=267 Participants	4 Participants n=272 Participants

PRIMARY outcome

Timeframe: Up to 31.5 Months

Population: Full Analysis Set (FAS) includes all enrolled participants who received any study drug.

ORR is defined as the Percent of participants with a confirmed objective response of complete response (CR) or partial response (PR) based on Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) by investigator assessment

Outcome measures

Measure	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 Participants Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 Participants Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 Participants Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 Participants Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 Participants Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule
Objective Response Rate (ORR)	5.3 Percentage of participants Interval 0.1 to 26.0	46.2 Percentage of participants Interval 19.2 to 74.9	6.3 Percentage of participants Interval 0.2 to 30.2	25.0 Percentage of participants Interval 0.6 to 80.6	44.0 Percentage of participants Interval 24.4 to 65.1

SECONDARY outcome

Timeframe: Up to 31.5 months

Population: Safety Analysis Set (SAF) included all enrolled participants who received any study drug.

Number of participants with any treatment-emergent adverse event (TEAE), any serious TEAE, and any TEAE leading to discontinuation or death reported.

Outcome measures

Measure	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 Participants Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 Participants Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 Participants Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 Participants Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 Participants Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death Any serious TEAE	10 Participants	6 Participants	11 Participants	2 Participants	14 Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death Any TEAE leading to discontinuation	4 Participants	3 Participants	4 Participants	0 Participants	5 Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death Any TEAE leading to death	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Number of Participants With Any Treatment-emergent Adverse Event (TEAE), Any Serious TEAE, and Any TEAE Leading to Discontinuation or Death Any TEAE	19 Participants	13 Participants	16 Participants	4 Participants	25 Participants

SECONDARY outcome

Timeframe: Up to 31.5 months

Population: Safety Analysis Set (SAF) included all enrolled participants who received any study drug.

Number of participants per NCI CTCAE version 5.0 Adverse Event Grade reported:

Grade 1 Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated Grade 2 Moderate; minimal, local, or non-invasive intervention indicated; limiting age-appropriate instrumental activities of daily living Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limited self-care activities of daily living Grade 4 Life-threatening consequences: urgent intervention indicated Grade 5 Death related to adverse event

Outcome measures

Measure	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 Participants Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 Participants Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 Participants Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 Participants Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 Participants Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 2 Moderate	6 Participants	6 Participants	4 Participants	1 Participants	6 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 1 Mild	2 Participants	2 Participants	2 Participants	0 Participants	2 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 3 Severe	10 Participants	2 Participants	8 Participants	3 Participants	11 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 4 Life-threatening	1 Participants	3 Participants	1 Participants	0 Participants	1 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade 5 Death	0 Participants	0 Participants	1 Participants	0 Participants	4 Participants
Severity of TEAEs as Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Missing	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 31.5 months

Population: Number of participants analyzed for DOR included only participants with confirmed complete response (CR) or partial response (PR)

DOR is defined as the time from date of first documented response (CR or PR) to date of documented progressive disease (PD), based on RECIST v1.1, per investigator

Outcome measures

Measure	Cohort A2: CMP-001+Cemiplimab for CSCC n=1 Participants Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=6 Participants Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=1 Participants Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=1 Participants Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort A1: CMP-001+Cemiplimab for CSCC n=11 Participants Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule
Duration of Response (DOR)	NA Months Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval	NA Months Interval 4.2 to Median duration of DOR not reached; Insufficient number of participants with events for estimated upper confidence interval	NA Months Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval	NA Months Median duration of DOR not reached; Insufficient number of participants with events for estimated lower and upper confidence interval	11.3 Months Interval 3.5 to Insufficient number of participants with events for estimated upper confidence interval

SECONDARY outcome

Timeframe: Up to 31.5 months

Population: Full Analysis Set (FAS) includes all enrolled participants who received any study drug.

PFS is defined as the time from date of first dose of study treatment to date of documented PD based on RECIST v1.1 or death, whichever occurs first

Outcome measures

Measure	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 Participants Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 Participants Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 Participants Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 Participants Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 Participants Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule
Progression Free Survival (PFS)	2.0 Months Interval 1.5 to 3.9	10.4 Months Interval 4.0 to Insufficient number of participants with events for estimated upper confidence interval	3.7 Months Interval 2.0 to Insufficient number of participants with events for estimated upper confidence interval	NA Months Interval 2.1 to Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval	10.3 Months Interval 5.6 to Insufficient number of participants with events for estimated upper confidence interval

SECONDARY outcome

Timeframe: Up to 31.5 months

Population: Full Analysis Set (FAS) includes all enrolled participants who received any study drug.

OS is defined as the time from date of first dose of study treatment to date of death

Outcome measures

Measure	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 Participants Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 Participants Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 Participants Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 Participants Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 Participants Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule
Overall Survival (OS)	12.7 Months Interval 6.7 to Insufficient number of participants with events for estimated upper confidence interval	NA Months Interval 10.9 to Median duration of PFS not reached; Insufficient number of participants with events for estimated upper confidence interval	9.9 Months Interval 4.9 to Insufficient number of participants with events for estimated upper confidence interval	NA Months Median duration of PFS not reached; Insufficient number of participants with events for estimated lower and upper confidence interval	15.6 Months Interval 10.9 to Insufficient number of participants with events for estimated upper confidence interval

Adverse Events

Cohort A1: CMP-001+Cemiplimab for CSCC

Serious events: 14 serious events

Other events: 24 other events

Deaths: 8 deaths

Cohort A2: CMP-001+Cemiplimab for CSCC

Serious events: 11 serious events

Other events: 19 other events

Deaths: 8 deaths

Cohort B1: CMP-001+Cemiplimab for MCC

Serious events: 6 serious events

Other events: 13 other events

Deaths: 4 deaths

Cohort B2: CMP-001+Cemiplimab for MCC

Serious events: 11 serious events

Other events: 15 other events

Deaths: 9 deaths

Cohort D: CMP-001+Cemiplimab for BCC

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 participants at risk Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 participants at risk Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 participants at risk Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 participants at risk Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 participants at risk Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule
General disorders Injection site reaction	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Death	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Fatigue	4.0% 1/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Incarcerated hernia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Pyrexia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Pneumonia	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Sepsis	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Wound infection	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Cellulitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Periorbital cellulitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Septic shock	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Sinusitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Skin infection	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Immune system disorders Cytokine release syndrome	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Immune system disorders Hypersensitivity	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Injury, poisoning and procedural complications Fall	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Injury, poisoning and procedural complications Skin laceration	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Seizure	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Transient ischaemic attack	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	4.0% 1/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Respiratory failure	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Myocarditis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Hepatobiliary disorders Hepatic steatosis	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Alanine aminotransferase increased	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Aspartate aminotransferase increased	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood alkaline phosphatase increased	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Deep vein thrombosis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Hypertension	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Lymphoedema	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Peripheral vein stenosis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Blood and lymphatic system disorders Anaemia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Abdominal pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Stomatitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Cerebrovascular accident	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Dizziness	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Ischaemic stroke	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Presyncope	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Chronic respiratory failure	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Cardiac arrest	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Atrial fibrillation	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Myocardial infarction	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Amylase increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood creatinine increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Lipase increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Dehydration	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Skin ulcer	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Hypotension	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Confusional state	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Acute kidney injury	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Ureteric obstruction	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.

Other adverse events

Measure	Cohort A1: CMP-001+Cemiplimab for CSCC n=25 participants at risk Participants who have not received prior systemic therapy for advanced cutaneous squamous cell carcinoma (CSCC) received CMP-001 intratumorally (IT) + cemiplimab intravenously (IV) according to the treatment schedule	Cohort A2: CMP-001+Cemiplimab for CSCC n=19 participants at risk Participants who have progressed on prior programmed cell death protein 1 (PD-1) therapy for advanced CSCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B1: CMP-001+Cemiplimab for MCC n=13 participants at risk Participants who had not received prior systemic therapy for advanced merkel cell carcinoma (MCC) received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort B2: CMP-001+Cemiplimab for MCC n=16 participants at risk Participants who have progressed on prior PD-1 therapy for advanced MCC received CMP-001 IT + cemiplimab IV according to the treatment schedule	Cohort D: CMP-001+Cemiplimab for BCC n=4 participants at risk Participants who have not received prior systemic therapy for advanced BCC (hedgehog pathway inhibitor or anti-PD-1/programmed cell death ligand 1 \[PD-L1\]) received CMP-001 IT + cemiplimab IV according to the treatment schedule
General disorders Asthenia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Facial pain	4.0% 1/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Injection site swelling	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Localised oedema	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Axillary pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Chest discomfort	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Crepitations	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Feeling cold	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Gait disturbance	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Infusion site reaction	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Injection site erythema	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Injection site pruritus	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Injection site rash	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Malaise	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 11 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Obstruction	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 8 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	18.8% 3/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Peripheral swelling	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Swelling	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Diarrhoea	36.0% 9/25 • Number of events 12 • From signing of informed consent through end of study up to approximately 31.5 months.	21.1% 4/19 • Number of events 7 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Nausea	32.0% 8/25 • Number of events 9 • From signing of informed consent through end of study up to approximately 31.5 months.	36.8% 7/19 • Number of events 15 • From signing of informed consent through end of study up to approximately 31.5 months.	61.5% 8/13 • Number of events 11 • From signing of informed consent through end of study up to approximately 31.5 months.	31.2% 5/16 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	50.0% 2/4 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Vomiting	20.0% 5/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	50.0% 2/4 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Constipation	16.0% 4/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	38.5% 5/13 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Gastrooesophageal reflux disease	12.0% 3/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Abdominal pain	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Dry mouth	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Abdominal discomfort	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Chapped lips	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Dyspepsia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Gastric haemorrhage	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Gastritis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Oesophagitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Oral dysaesthesia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Gastrointestinal disorders Stomatitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Pruritus	36.0% 9/25 • Number of events 10 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	38.5% 5/13 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Dry skin	16.0% 4/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Rash	16.0% 4/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Actinic keratosis	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Rash maculo-papular	8.0% 2/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	23.1% 3/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Alopecia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Dermatitis	4.0% 1/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Erythema	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Blister	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Drug eruption	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations COVID-19	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Cellulitis	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Conjunctivitis	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Folliculitis	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Nasopharyngitis	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Periorbital cellulitis	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Pneumonia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Skin infection	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Urinary tract infection	4.0% 1/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Bronchitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Diverticulitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Oral candidiasis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Sinusitis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Upper respiratory tract infection	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Neutrophil count decreased	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood bilirubin increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood creatine increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood urea increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Haemoglobin increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Human chorionic gonadotropin increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Hypoaesthesia	4.0% 1/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Paraesthesia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Peripheral sensory neuropathy	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hyperglycaemia	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hyperkalaemia	8.0% 2/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypoalbuminaemia	8.0% 2/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hyponatraemia	8.0% 2/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	21.1% 4/19 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Dehydration	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypercalcaemia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypophosphataemia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Lymphoedema	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Peripheral arterial occlusive disease	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Chronic kidney disease	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Acute kidney injury	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Urinary incontinence	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Urinary retention	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Haematuria	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Hydronephrosis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Pollakiuria	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Ureteric obstruction	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Renal and urinary disorders Urinary tract pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Sinus bradycardia	12.0% 3/25 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Sinus tachycardia	8.0% 2/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Tachycardia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Atrial fibrillation	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Bradycardia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Cardiac disorders Myocarditis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Injury, poisoning and procedural complications Fall	16.0% 4/25 • Number of events 7 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	23.1% 3/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Injury, poisoning and procedural complications Injection related reaction	8.0% 2/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Injury, poisoning and procedural complications Buttock injury	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Eye disorders Vision blurred	8.0% 2/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Eye disorders Lacrimation increased	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Eye disorders Periorbital oedema	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Eye disorders Eye swelling	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Eye disorders Night blindness	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	12.0% 3/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Blood and lymphatic system disorders Eosinophilia	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Blood and lymphatic system disorders Lymph node pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Anhedonia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Anxiety	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Confusional state	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Delirium	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Depression	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Disorientation	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Ear and labyrinth disorders Aural polyp	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Ear and labyrinth disorders Tinnitus	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Ear and labyrinth disorders Vertigo	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Reproductive system and breast disorders Scrotal swelling	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Fatigue	60.0% 15/25 • Number of events 29 • From signing of informed consent through end of study up to approximately 31.5 months.	52.6% 10/19 • Number of events 12 • From signing of informed consent through end of study up to approximately 31.5 months.	61.5% 8/13 • Number of events 13 • From signing of informed consent through end of study up to approximately 31.5 months.	50.0% 8/16 • Number of events 16 • From signing of informed consent through end of study up to approximately 31.5 months.	75.0% 3/4 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Chills	40.0% 10/25 • Number of events 19 • From signing of informed consent through end of study up to approximately 31.5 months.	57.9% 11/19 • Number of events 24 • From signing of informed consent through end of study up to approximately 31.5 months.	76.9% 10/13 • Number of events 24 • From signing of informed consent through end of study up to approximately 31.5 months.	50.0% 8/16 • Number of events 13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Pyrexia	24.0% 6/25 • Number of events 9 • From signing of informed consent through end of study up to approximately 31.5 months.	42.1% 8/19 • Number of events 19 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 4/16 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Injection site pain	16.0% 4/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 10 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Injection site reaction	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Oedema peripheral	12.0% 3/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	30.8% 4/13 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	18.8% 3/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Face oedema	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Influenza like illness	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
General disorders Non-cardiac chest pain	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Infections and infestations Wound infection	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Aspartate aminotransferase increased	20.0% 5/25 • Number of events 7 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	23.1% 3/13 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Alanine aminotransferase increased	16.0% 4/25 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	23.1% 3/13 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Lipase increased	16.0% 4/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	50.0% 2/4 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Lymphocyte count decreased	16.0% 4/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Amylase increased	12.0% 3/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	50.0% 2/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood lactate dehydrogenase increased	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Weight decreased	12.0% 3/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Weight increased	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood alkaline phosphatase increased	8.0% 2/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Blood creatinine increased	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Platelet count decreased	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations International normalised ratio increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Troponin I increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Investigations Troponin T increased	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Headache	16.0% 4/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	26.3% 5/19 • Number of events 12 • From signing of informed consent through end of study up to approximately 31.5 months.	38.5% 5/13 • Number of events 7 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Dizziness	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	23.1% 3/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	18.8% 3/16 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Dysgeusia	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Restless legs syndrome	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Syncope	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Amnesia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Nervous system disorders Neuralgia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Decreased appetite	20.0% 5/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypokalaemia	20.0% 5/25 • Number of events 7 • From signing of informed consent through end of study up to approximately 31.5 months.	21.1% 4/19 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Back pain	24.0% 6/25 • Number of events 10 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	30.8% 4/13 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	31.2% 5/16 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Pain in extremity	12.0% 3/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	23.1% 3/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	18.8% 3/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Arthralgia	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	30.8% 4/13 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Myalgia	8.0% 2/25 • Number of events 5 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	30.8% 4/13 • Number of events 15 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Neck pain	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Joint effusion	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Nose deformity	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Musculoskeletal and connective tissue disorders Synovial cyst	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Cough	12.0% 3/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	18.8% 3/16 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	8.0% 2/25 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Pneumonitis	8.0% 2/25 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	15.8% 3/19 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Productive cough	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Respiratory, thoracic and mediastinal disorders Sinus pain	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Hypertension	20.0% 5/25 • Number of events 8 • From signing of informed consent through end of study up to approximately 31.5 months.	26.3% 5/19 • Number of events 6 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Hypotension	16.0% 4/25 • Number of events 12 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 4/16 • Number of events 9 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Deep vein thrombosis	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Flushing	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Vascular disorders Hot flush	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 4 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Endocrine disorders Adrenal insufficiency	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Endocrine disorders Hyperthyroidism	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Endocrine disorders Hypothyroidism	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	10.5% 2/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Eye disorders Dry eye	8.0% 2/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	25.0% 1/4 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm swelling	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	6.2% 1/16 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Blood and lymphatic system disorders Anaemia	8.0% 2/25 • Number of events 8 • From signing of informed consent through end of study up to approximately 31.5 months.	36.8% 7/19 • Number of events 9 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	37.5% 6/16 • Number of events 10 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Blood and lymphatic system disorders Lymphadenopathy mediastinal	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Immune system disorders Cytokine release syndrome	4.0% 1/25 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	15.4% 2/13 • Number of events 3 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Immune system disorders Drug hypersensitivity	0.00% 0/25 • From signing of informed consent through end of study up to approximately 31.5 months.	5.3% 1/19 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/13 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/16 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.
Psychiatric disorders Insomnia	4.0% 1/25 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/19 • From signing of informed consent through end of study up to approximately 31.5 months.	7.7% 1/13 • Number of events 1 • From signing of informed consent through end of study up to approximately 31.5 months.	12.5% 2/16 • Number of events 2 • From signing of informed consent through end of study up to approximately 31.5 months.	0.00% 0/4 • From signing of informed consent through end of study up to approximately 31.5 months.

Additional Information

Clinical Trials Administrator

Regeneron Pharmaceuticals, Inc.

Phone: 844-734-6643

Email: clinicaltrials@regeneron.com

Results disclosure agreements

• Principal investigator is a sponsor employee The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.
• Publication restrictions are in place

Restriction type: OTHER