Trial Outcomes & Findings for Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour (NCT NCT03593226)

Last Updated: 2025-02-14

Results Overview

Safety and tolerability of AGI-134 injected intra-tumourally (IT) by assessment of the percentage of participants who experienced a dose-limiting toxicity (DLT) . DLTs will be assessed during the first cycle (21 days)

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

38 participants

Primary outcome timeframe

Up to 3 weeks after first administration of each dose level

Results posted on

2025-02-14

Participant Flow

Participant milestones

Participant milestones
Measure	AGI-134 25 mg 25 mg AGI-134 (1 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 50 mg 50 mg AGI-134 (2 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 100 mg 100 mg AGI-134 (4 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 200 mg 200 mg AGI-134 (8 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
Overall Study STARTED	6	19	7	6
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	6	19	7	6

Reasons for withdrawal

Reasons for withdrawal
Measure	AGI-134 25 mg 25 mg AGI-134 (1 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 50 mg 50 mg AGI-134 (2 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 100 mg 100 mg AGI-134 (4 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 200 mg 200 mg AGI-134 (8 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
Overall Study Disease progression	6	13	5	6
Overall Study Adverse Event	0	1	0	0
Overall Study Withdrawal by Subject	0	4	1	0
Overall Study Physician Decision	0	1	0	0
Overall Study Clinical disease progression	0	0	1	0

Baseline Characteristics

Study to Evaluate Safety & Tolerability of AGI-134 in Solid Tumour

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	AGI-134 25mg/1mL n=6 Participants AGI-134 1mL via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 50mg/2mL n=19 Participants AGI-134 2mL via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 100mg/4mL n=7 Participants AGI-134 4mL via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 200mg/8mL n=6 Participants AGI-134 8mL via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants	11 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	20 Participants n=21 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	18 Participants n=21 Participants
Age, Continuous	67.8 years STANDARD_DEVIATION 8.2 • n=5 Participants	59.95 years STANDARD_DEVIATION 13.4 • n=7 Participants	54 years STANDARD_DEVIATION 11 • n=5 Participants	59.2 years STANDARD_DEVIATION 18.5 • n=4 Participants	60 years STANDARD_DEVIATION 13.9 • n=21 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	11 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	17 Participants n=21 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	8 Participants n=7 Participants	5 Participants n=5 Participants	3 Participants n=4 Participants	21 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	19 Participants n=7 Participants	6 Participants n=5 Participants	5 Participants n=4 Participants	36 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United Kingdom	2 participants n=5 Participants	12 participants n=7 Participants	6 participants n=5 Participants	4 participants n=4 Participants	24 participants n=21 Participants
Region of Enrollment Israel	2 participants n=5 Participants	3 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	5 participants n=21 Participants
Region of Enrollment Spain	2 participants n=5 Participants	4 participants n=7 Participants	1 participants n=5 Participants	2 participants n=4 Participants	9 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 3 weeks after first administration of each dose level

Outcome measures

Outcome measures
Measure	AGI-134 25 mg n=6 Participants 25 mg AGI-134 (1 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.	AGI-134 50 mg n=19 Participants 50 mg AGI-134 (2 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.	AGI-134 100 mg n=7 Participants 100 mg AGI-134 (4 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.	AGI-134 200 mg n=6 Participants 200 mg AGI-134 (8 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.
Safety and Tolerability of AGI-134 Injected Intra-tumourally (IT)	0 Participants	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: Approximately 12 months

Percentage of Participants Who Discontinue Study Drug Due to an Adverse Event (AE) AEs are defined as any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of study treatment or protocol-specified procedure, whether or not considered related to the study treatment or protocol-specified procedure. Any worsening (i.e., any clinically significant adverse change in frequency and/or intensity) of a pre-existing condition that is temporally associated with the use of the study treatment, is also an AE. The percentage of participants who discontinue study treatment due to an AE will be presented

Outcome measures

Outcome measures
Measure	AGI-134 25 mg n=6 Participants 25 mg AGI-134 (1 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.	AGI-134 50 mg n=19 Participants 50 mg AGI-134 (2 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.	AGI-134 100 mg n=7 Participants 100 mg AGI-134 (4 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.	AGI-134 200 mg n=6 Participants 200 mg AGI-134 (8 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists of three weeks, dosing will be given for 4 cycles.
Discontinue Study Drug Due to an Adverse Events	0 Participants	1 Participants	0 Participants	0 Participants

Adverse Events

Overall

Serious events: 18 serious events

Other events: 38 other events

Deaths: 1 deaths

AGI-134 25 mg

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

AGI-134 50 mg

Serious events: 8 serious events

Other events: 19 other events

Deaths: 0 deaths

AGI-134 100 mg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

AGI-134 200 mg

Serious events: 5 serious events

Other events: 6 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Overall n=38 participants at risk Safety Population (all treated participants)	AGI-134 25 mg n=6 participants at risk 25 mg AGI-134 (1 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 50 mg n=19 participants at risk 50 mg AGI-134 (2 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 100 mg n=7 participants at risk 100 mg AGI-134 (4 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 200 mg n=6 participants at risk 200 mg AGI-134 (8 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
Infections and infestations Catheter site infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Nausea	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Fatigue	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Cardiac disorders Bradycardia	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Chills	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Hypotension	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Groin infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Injury, poisoning and procedural complications Injection related reaction	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Skin infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Syncope	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Abdominal pain	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Lower respiratory tract infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Localised infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Blood and lymphatic system disorders Anaemia	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Injection site infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Renal and urinary disorders Acute kidney injury	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Renal and urinary disorders Oliguria	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Reproductive system and breast disorders Pelvic pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Vomiting	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Pyrexia	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Cardiac disorders Pericardial effusion	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hyponatraemia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Immune system disorders Hypersensitivity	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Psychiatric disorders Confusional state	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Cellulitis	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Wound infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.

Other adverse events

Other adverse events
Measure	Overall n=38 participants at risk Safety Population (all treated participants)	AGI-134 25 mg n=6 participants at risk 25 mg AGI-134 (1 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 50 mg n=19 participants at risk 50 mg AGI-134 (2 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 100 mg n=7 participants at risk 100 mg AGI-134 (4 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.	AGI-134 200 mg n=6 participants at risk 200 mg AGI-134 (8 mL) via IT injection. The proposed treatment is one dose of AGI-134 monotherapy per cycle; each cycle consists in three weeks, dosing will be given for 4 cycles.
Blood and lymphatic system disorders Anaemia	18.4% 7/38 • Number of events 15 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	21.1% 4/19 • Number of events 12 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Blood and lymphatic system disorders Leukocytosis	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Blood and lymphatic system disorders Lymphopenia	10.5% 4/38 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Blood and lymphatic system disorders Lymph node pain	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Blood and lymphatic system disorders Lymphadenopathy	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Cardiac disorders Bradycardia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Cardiac disorders Tachycardia	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Cardiac disorders Supraventricular extrasystoles	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Eye disorders Periorbital oedema	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Eye disorders Asthenopia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Toothache	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Diarrhoea	13.2% 5/38 • Number of events 8 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	15.8% 3/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Dyspepsia	7.9% 3/38 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Abdominal pain	5.3% 2/38 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Abdominal pain upper	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Constipation	10.5% 4/38 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Nausea	23.7% 9/38 • Number of events 14 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	21.1% 4/19 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	28.6% 2/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Vomiting	28.9% 11/38 • Number of events 16 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	31.6% 6/19 • Number of events 8 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	28.6% 2/7 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	50.0% 3/6 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Mouth haemorrhage	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Lip pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Oral Pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Parotid gland haemorrhage	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Stomatitis	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Tongue movement disturbance	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Asthenia	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Fatigue	36.8% 14/38 • Number of events 22 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	50.0% 3/6 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	31.6% 6/19 • Number of events 13 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	57.1% 4/7 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Malaise	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Pyrexia	13.2% 5/38 • Number of events 10 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	15.8% 3/19 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Chills	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Feeling hot	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Peripheral swelling	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Injection site bruising	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Injection site discharge	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Injection site discomfort	5.3% 2/38 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Injection site erythema	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Injection site oedema	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Injection site pain	26.3% 10/38 • Number of events 13 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	42.9% 3/7 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	50.0% 3/6 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Injection site swelling	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Nodule	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Oedema peripheral	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Chest pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Chest discomfort	10.5% 4/38 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Non-cardiac chest pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
General disorders Pain	5.3% 2/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Hepatobiliary disorders Hepatic pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Cellulitis	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	15.8% 3/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Oral candidiasis	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations COVID-19	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Conjunctivitis	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Hepatic infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Groin infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Injection site infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Wound infection	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Lower respiratory tract infection	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Pseudomonas infection	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Infections and infestations Urinary tract infection	10.5% 4/38 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	15.8% 3/19 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Injury, poisoning and procedural complications Ligament sprain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Injury, poisoning and procedural complications Muscle strain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Injury, poisoning and procedural complications Fall	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Injury, poisoning and procedural complications Incision site pain	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Injury, poisoning and procedural complications Post procedural contusion	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Injury, poisoning and procedural complications Skin laceration	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Activated partial thromboplastin time shortened	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Fibrin D dimer increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Electrocardiogram QT prolonged	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Blood bilirubin increased	2.6% 1/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Past-pointing	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Weight decreased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Weight increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Platelet count increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Blood albumin increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations C-reactive protein increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Protein total decreased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Blood urea increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Blood alkaline phosphatase decreased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Blood alkaline phosphatase increased	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Blood lactate dehydrogenase increased	10.5% 4/38 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Protein urine present	5.3% 2/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Neutrophil count decreased	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Neutrophil count increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Decreased appetite	21.1% 8/38 • Number of events 9 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	31.6% 6/19 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Increased appetite	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hypercalcaemia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hyperchloraemia	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hyperglycaemia	5.3% 2/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hypoglycaemia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hyperphosphataemia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hyperkalaemia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hypoalbuminaemia	10.5% 4/38 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	66.7% 4/6 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Metabolism and nutrition disorders Hyponatraemia	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Pain in jaw	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Arthralgia	13.2% 5/38 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	28.6% 2/7 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Joint range of motion decreased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Myalgia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Muscle spasms	10.5% 4/38 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Muscular weakness	5.3% 2/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Back pain	15.8% 6/38 • Number of events 10 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	15.8% 3/19 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Flank pain	5.3% 2/38 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	5.3% 2/38 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Musculoskeletal and connective tissue disorders Pain in extremity	10.5% 4/38 • Number of events 8 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	2.6% 1/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour ulceration	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin neoplasm bleeding	2.6% 1/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Balance disorder	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Somnolence	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Syncope	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Dyskinesia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Headache	15.8% 6/38 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	57.1% 4/7 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Memory impairment	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Dizziness	21.1% 8/38 • Number of events 9 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	26.3% 5/19 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Presyncope	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Paraesthesia	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Neuropathy peripheral	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Psychiatric disorders Anxiety	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Psychiatric disorders Insomnia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Psychiatric disorders Depressed mood	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Psychiatric disorders Panic attack	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Psychiatric disorders Libido increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Renal and urinary disorders Bladder dilatation	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Renal and urinary disorders Acute kidney injury	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Renal and urinary disorders Urinary tract discomfort	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Reproductive system and breast disorders Pelvic pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Reproductive system and breast disorders Vulvovaginal inflammation	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Dyspnoea	13.2% 5/38 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	33.3% 2/6 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Hypoxia	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Cough	10.5% 4/38 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	10.5% 2/19 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Productive cough	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Pleural effusion	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Aspiration	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Increased upper airway secretion	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Alopecia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Hyperhidrosis	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Night sweats	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Erythema	13.2% 5/38 • Number of events 5 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	15.8% 3/19 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Skin exfoliation	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Pruritus	21.1% 8/38 • Number of events 11 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	21.1% 4/19 • Number of events 6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	42.9% 3/7 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Purpura	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Rash	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Skin mass	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Surgical and medical procedures Tooth extraction	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Peripheral venous disease	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Hyperaemia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Deep vein thrombosis	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Flushing	7.9% 3/38 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	15.8% 3/19 • Number of events 4 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Hot flush	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Peripheral coldness	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Hypertension	5.3% 2/38 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	28.6% 2/7 • Number of events 2 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Systolic hypertension	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Vascular disorders Hypotension	7.9% 3/38 • Number of events 3 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	14.3% 1/7 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Gastrointestinal disorders Dysphagia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Hepatobiliary disorders Hepatomegaly	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Aspartate aminotransferase increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Investigations Blood uric acid increased	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Nervous system disorders Neuralgia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Renal and urinary disorders Chronic kidney disease	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Dysphonia	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Respiratory, thoracic and mediastinal disorders Nasal congestion	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/19 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	16.7% 1/6 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.
Skin and subcutaneous tissue disorders Skin burning sensation	2.6% 1/38 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	5.3% 1/19 • Number of events 1 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/7 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.	0.00% 0/6 • AEs collected during the course of the study from Informed Consent Form (ICF) signature time until study completed or ceased, approximately 12 months.

Additional Information

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Results disclosure agreements

Principal investigator is a sponsor employee The restrictions are as per the signed agreement with each PI and institution.
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