Trial Outcomes & Findings for Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma (NCT NCT01397708)

Last Updated: 2025-10-29

Results Overview

Evaluation will be based on the incidence, intensity, and type of Adverse Events (AEs). Clinically significant changes in the subjects' physical examinations, vital signs, and ECG evaluations, and clinical manifestations relevant to abnormal laboratory values will be captured as AEs.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

26 participants

Primary outcome timeframe

From the signing of informed consent until 28 days after the last dose of study treatment, up to 28 weeks

Results posted on

2025-10-29

Participant Flow

Participant milestones

Participant milestones
Measure	Phase I: 5mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Overall Study STARTED	3	3	3	4	4	4	3	2
Overall Study COMPLETED	3	3	1	3	3	4	2	1
Overall Study NOT COMPLETED	0	0	2	1	1	0	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Phase 1: 100mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Overall Study Withdrawal by Subject	1	0	0	0	1
Overall Study Death	1	1	0	0	0
Overall Study Lost to Follow-up	0	0	1	0	0
Overall Study Other	0	0	0	1	0

Baseline Characteristics

Safety Study of Adenovirus Vector Engineered to Express hIL-12 in Combination With Activator Ligand to Treat Melanoma

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=4 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=4 Participants Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=4 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD n=3 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD n=2 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days	Total n=26 Participants Total of all reporting groups
Age, Continuous	45.0 years n=5 Participants	71.0 years n=7 Participants	73.0 years n=5 Participants	59.5 years n=4 Participants	70.0 years n=21 Participants	54.0 years n=8 Participants	63.0 years n=8 Participants	55.0 years n=24 Participants	64.0 years n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	8 Participants n=42 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	18 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	26 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	4 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	2 Participants n=24 Participants	25 Participants n=42 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	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants
Height	182.50 cm STANDARD_DEVIATION 12.471 • n=5 Participants	172.27 cm STANDARD_DEVIATION 12.329 • n=7 Participants	154.90 cm STANDARD_DEVIATION 3.439 • n=5 Participants	170.65 cm STANDARD_DEVIATION 12.619 • n=4 Participants	174.95 cm STANDARD_DEVIATION 11.103 • n=21 Participants	171.10 cm STANDARD_DEVIATION 10.370 • n=8 Participants	174.00 cm STANDARD_DEVIATION 8.900 • n=8 Participants	186.10 cm STANDARD_DEVIATION 5.515 • n=24 Participants	172.69 cm STANDARD_DEVIATION 12.080 • n=42 Participants
Weight	88.30 kg STANDARD_DEVIATION 15.679 • n=5 Participants	77.27 kg STANDARD_DEVIATION 21.388 • n=7 Participants	59.60 kg STANDARD_DEVIATION 8.931 • n=5 Participants	87.65 kg STANDARD_DEVIATION 11.577 • n=4 Participants	80.53 kg STANDARD_DEVIATION 8.034 • n=21 Participants	77.75 kg STANDARD_DEVIATION 20.012 • n=8 Participants	81.03 kg STANDARD_DEVIATION 14.380 • n=8 Participants	64.90 kg STANDARD_DEVIATION 1.556 • n=24 Participants	78.16 kg STANDARD_DEVIATION 15.340 • n=42 Participants
BMI	26.408 kg/m2 STANDARD_DEVIATION 2.8240 • n=5 Participants	25.645 kg/m2 STANDARD_DEVIATION 3.7322 • n=7 Participants	24.796 kg/m2 STANDARD_DEVIATION 3.0863 • n=5 Participants	30.542 kg/m2 STANDARD_DEVIATION 6.4765 • n=4 Participants	26.508 kg/m2 STANDARD_DEVIATION 3.7585 • n=21 Participants	26.541 kg/m2 STANDARD_DEVIATION 6.3030 • n=8 Participants	26.660 kg/m2 STANDARD_DEVIATION 3.4900 • n=8 Participants	18.777 kg/m2 STANDARD_DEVIATION 1.5615 • n=24 Participants	26.248 kg/m2 STANDARD_DEVIATION 4.7793 • n=42 Participants

PRIMARY outcome

Timeframe: From the signing of informed consent until 28 days after the last dose of study treatment, up to 28 weeks

Population: All safety analyses will be conducted on the Safety population. The Safety population is defined as all patients who receive at least one INXN-1001 capsule or, in the event an injection of INXN-2001 is administered before an INXN-1001 capsule is taken, at least one injection of INXN-2001. The Safety population will be used for the analysis of safety data based on the actual initial dose of INXN-1001 received.

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=4 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=4 Participants Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=4 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD n=3 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD n=2 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Number of Participants With Treatment-Emergent Adverse Events Treatment-emergent SAE	0 participants	0 participants	1 participants	2 participants	3 participants	3 participants	2 participants	2 participants
Number of Participants With Treatment-Emergent Adverse Events DLT	0 participants	0 participants	0 participants	0 participants	1 participants	1 participants	1 participants	0 participants
Number of Participants With Treatment-Emergent Adverse Events Any TEAE	3 participants	3 participants	3 participants	4 participants	4 participants	4 participants	3 participants	2 participants
Number of Participants With Treatment-Emergent Adverse Events Drug-related TEAE	3 participants	3 participants	3 participants	4 participants	4 participants	4 participants	3 participants	2 participants
Number of Participants With Treatment-Emergent Adverse Events Drug-related Grade 3 or higher TEAE	0 participants	0 participants	2 participants	2 participants	3 participants	3 participants	3 participants	2 participants
Number of Participants With Treatment-Emergent Adverse Events TEAE leading to death	0 participants	0 participants	0 participants	1 participants	0 participants	0 participants	0 participants	0 participants

SECONDARY outcome

Timeframe: Samples were collected in Cycle 1 on Day 1 (pre-dose and 0.5, 1, 2, 4, and 6 hours post-dose), Day 2 (pre-dose), Day 7 (pre-dose and 1-2 and 4-6 hours post-dose), and Day 8 (24 hours after the Day 7 dose).

Population: The PK Population includes all subjects who received at least one dose of INXN-1001 and had sufficient plasma concentration data to derive reliable PK parameters.

The area under the plasma concentration versus time curve from time 0 to the last measurable concentration (AUC0-t) for INXN-1001, calculated during the first treatment cycle.

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=8 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=4 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=2 Participants Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Area Under the Plasma Concentration-Time Curve (AUC) of INXN-1001 (Veledimex) in Cycle 1 C1D1 AUC0-24 (ng*h/mL)	11701 ng*h/mL Standard Deviation 2925	10225 ng*h/mL Standard Deviation 6214	16626 ng*h/mL Standard Deviation 12910	10322 ng*h/mL Standard Deviation 777	8364 ng*h/mL Standard Deviation 5771	—	—	—
Area Under the Plasma Concentration-Time Curve (AUC) of INXN-1001 (Veledimex) in Cycle 1 C1D7 AUC0-t (ng*h/mL)	15900 ng*h/mL Standard Deviation 5960	14000 ng*h/mL Standard Deviation 1500	15700 ng*h/mL Standard Deviation 4640	11000 ng*h/mL	8945 ng*h/mL Standard Deviation 190	—	—	—
Area Under the Plasma Concentration-Time Curve (AUC) of INXN-1001 (Veledimex) in Cycle 1 C1D1 Dose-normalized m2/mg AUC0-24 (ng*h/mL)	194 ng*h/mL Standard Deviation 16.1	148 ng*h/mL Standard Deviation 96	197 ng*h/mL Standard Deviation 105	193 ng*h/mL Standard Deviation 38	186 ng*h/mL Standard Deviation 135	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study treatment for up to 1 year.

Population: Subjects with at least one post baseline evaluation. Two subjects were enrolled in the 80 mg QOD arm. Both discontinued study treatment early and did not receive post-baseline tumor assessments. One subject completed scheduled visits but had no RECIST-evaluable imaging and was censored at baseline. Therefore, 0 subjects from this arm were included in the PFS analysis. The overall PFS-evaluable population included 17 subjects across all arms.

Progression-Free Survival (PFS) was defined as the time in days from the first dose of study treatment to the first assessment of disease progression or death from any cause, whichever occurred first. Subjects who withdrew from the study were censored at the date of their last non-progressive disease assessment. The final analysis was performed using Kaplan-Meier methodology to determine the median PFS.

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=2 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=2 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=3 Participants Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=3 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD n=1 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Progression-Free Survival (PFS)	79.0 Days Interval 71.0 to 79.0	76.5 Days Interval 74.0 to 79.0	29.5 Days Interval 15.0 to 44.0	58.0 Days Interval 57.0 to 64.0	64.0 Days Interval 38.0 to 64.0	77.0 Days Interval 27.0 to 162.0	91.0 Days Interval 91.0 to 91.0	—

SECONDARY outcome

Timeframe: Baseline (Screening) and at the Post-Treatment Safety Assessment (approximately 28 days after the end of Cycle 1).

Population: The analysis was performed on participants in the Safety Population who had paired (baseline and post-treatment) tumor biopsy samples suitable for qRT-PCR. Paired samples were required for inclusion. The number of participants analyzed per arm/group is lower than the total enrolled population because of limited biopsy availability, insufficient RNA yield, or RNA quality issues.

Tumor biopsy samples were analyzed for IL-12 mRNA expression using quantitative real-time polymerase chain reaction (qRT-PCR). Expression levels were normalized to the housekeeping gene ACTB (β-actin) and quantified using the ΔΔCt method. For each participant, the median ΔΔCt-based fold-change from baseline to post-treatment was calculated. These individual participant-level medians were then averaged to derive the mean of medians (measure type) across all participants within each arm/group. The reported values therefore reflect the mean of medians in arbitrary units (AU), representing relative IL-12 mRNA expression normalized to ACTB- calculated as 2\^(-ΔΔCt) fold-change relative to baseline Not all subjects in each arm contributed evaluable IL-12 mRNA expression data due to biopsy availability and RNA quality.

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=2 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=4 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Change From Baseline in Tumor IL-12 Messenger RNA (mRNA) Expression Change in IL-12 mRNA Expression Level (Arbitrary Units) IL-12 mRNA levels: C1D8-15	—	1716 Arbitrary Units (AU) Standard Deviation 2968	3 Arbitrary Units (AU) Standard Deviation 3	0 Arbitrary Units (AU) Standard Deviation 1	—	—	—	—
Change From Baseline in Tumor IL-12 Messenger RNA (mRNA) Expression Change in IL-12 mRNA Expression Level (Arbitrary Units) IL-12 mRNA levels: C1D1-7	7916 Arbitrary Units (AU)	6296 Arbitrary Units (AU) Standard Deviation 5958	2216 Arbitrary Units (AU) Standard Deviation 1012	4327 Arbitrary Units (AU) Standard Deviation 2516	—	—	—	—
Change From Baseline in Tumor IL-12 Messenger RNA (mRNA) Expression Change in IL-12 mRNA Expression Level (Arbitrary Units) IL-12 mRNA levels: C2D1-7	—	8866 Arbitrary Units (AU) Standard Deviation 15309	—	15 Arbitrary Units (AU)	—	—	—	—
Change From Baseline in Tumor IL-12 Messenger RNA (mRNA) Expression Change in IL-12 mRNA Expression Level (Arbitrary Units) IL-12 mRNA levels: C2D8-15	2178 Arbitrary Units (AU)	—	—	1 Arbitrary Units (AU)	—	—	—	—
Change From Baseline in Tumor IL-12 Messenger RNA (mRNA) Expression Change in IL-12 mRNA Expression Level (Arbitrary Units) IL-12 mRNA levels: C3D1-7	2648 Arbitrary Units (AU)	162946 Arbitrary Units (AU) Standard Deviation 239470	—	33 Arbitrary Units (AU) Standard Deviation 41	—	—	—	—
Change From Baseline in Tumor IL-12 Messenger RNA (mRNA) Expression Change in IL-12 mRNA Expression Level (Arbitrary Units) IL-12 mRNA levels: C3D8-15	—	82716 Arbitrary Units (AU) Standard Deviation 116949	—	68 Arbitrary Units (AU) Standard Deviation 116	—	—	—	—

SECONDARY outcome

Population: The PK Population includes all subjects who received at least one dose of INXN-1001 and had sufficient plasma concentration data to derive reliable PK parameters.

The maximum observed plasma concentration (Cmax) of INXN-1001 following oral administration, as determined from plasma sample analysis during the first treatment cycle

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=8 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=4 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=2 Participants Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Maximum Plasma Concentration (Cmax) of INXN-1001 (Veledimex) in Cycle 1 C1D1 Cmax (ng/mL)	962 ng/mL Standard Deviation 323	738 ng/mL Standard Deviation 417	1284 ng/mL Standard Deviation 855	809 ng/mL Standard Deviation 120	636 ng/mL Standard Deviation 465	—	—	—
Maximum Plasma Concentration (Cmax) of INXN-1001 (Veledimex) in Cycle 1 C1D7 Dose-normalized m2/mg Cmax (ng/mL)	—	16.2 ng/mL Standard Deviation 1.7	17.2 ng/mL Standard Deviation 5.6	—	—	—	—	—
Maximum Plasma Concentration (Cmax) of INXN-1001 (Veledimex) in Cycle 1 C1D1 Dose-normalized m2/mg Cmax (ng/mL)	16.2 ng/mL Standard Deviation 2.7	10.6 ng/mL Standard Deviation 6.3	15.5 ng/mL Standard Deviation 6.9	16.3 ng/mL Standard Deviation 3.7	14 ng/mL Standard Deviation 11	—	—	—
Maximum Plasma Concentration (Cmax) of INXN-1001 (Veledimex) in Cycle 1 C1D1 C24h (ng/mL)	81.9 ng/mL Standard Deviation 79.3	106 ng/mL Standard Deviation 105	86.8 ng/mL Standard Deviation 80.0	66.6 ng/mL Standard Deviation 38.6	78 ng/mL Standard Deviation 14	—	—	—
Maximum Plasma Concentration (Cmax) of INXN-1001 (Veledimex) in Cycle 1 C1D7 Cmax (ng/mL)	—	1400 ng/mL Standard Deviation 150	1570 ng/mL Standard Deviation 464	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline (Screening) and at Cycle 2, Day 7

Population: A total of 5 of the 26 treated subjects were included in this CTL analysis. Inclusion was based on the availability of paired peripheral blood samples at baseline and Cycle 2, Day 7

The percentage of Cytotoxic T-Lymphocytes (CTLs) within the CD8+ T-cell population was measured from serum samples by flow cytometry to assess changes in immune cell populations.

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD n=2 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Change From Baseline in Peripheral Blood Cytotoxic T-Lymphocytes (CTLs) CD3+CD8+ Median %cells at post-treatment safety assessment	—	28.75 % cells Standard Deviation 0	—	—	—	—	—	24.00 % cells Standard Deviation 0
Change From Baseline in Peripheral Blood Cytotoxic T-Lymphocytes (CTLs) CD3+CD8+ Median %cells at Screening	—	30.90 % cells Standard Deviation 0	—	—	—	—	—	25.40 % cells Standard Deviation 0
Change From Baseline in Peripheral Blood Cytotoxic T-Lymphocytes (CTLs) CD3+CD8+ Median %cells at C2D15	—	33.00 % cells Standard Deviation 0	—	—	—	—	—	28.60 % cells Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline (Screening) and at Cycle 2, Day 7.

Population: A total of 5 of the 26 treated subjects were included in this final analysis of peripheral blood Regulatory T-cell levels. Inclusion required availability of paired serum samples from Baseline and Cycle 2, Day 7.

The percentage of Regulatory T-cells (Tregs) in peripheral blood lymphocytes was measured from serum samples by flow cytometry to assess changes in immune cell populations.

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD n=2 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Change From Baseline in Peripheral Blood Regulatory T-cells (Tregs) CD3+CD4+ Median %cells at Screening	—	45.00 %cells Standard Deviation 0	—	—	—	—	—	37.30 %cells Standard Deviation 0
Change From Baseline in Peripheral Blood Regulatory T-cells (Tregs) CD3+CD4+ Median %cells at C2D15	—	34.45 %cells Standard Deviation 0	—	—	—	—	—	48.30 %cells Standard Deviation 0
Change From Baseline in Peripheral Blood Regulatory T-cells (Tregs) CD3+CD4+ Median %cells at post-treatment safety assessment	—	31.25 %cells Standard Deviation 0	—	—	—	—	—	24.00 %cells Standard Deviation 0

SECONDARY outcome

Timeframe: Baseline (Screening) and at the Post-Treatment Safety Assessment (28 days after the end of Cycle 1).

Population: The analysis was performed on subjects from the Safety Population who had paired (baseline and post-treatment) tumor biopsy samples available for interferon-gamma (IFN-γ) mRNA analysis. A total of 12 of the 26 treated subjects were included in this final analysis. The number of participants analyzed per cohort reflects those who contributed data at any post-baseline time point, even if data were not available at all scheduled intervals.

Tumor biopsy samples were analyzed for IFN-γ mRNA expression using quantitative real-time polymerase chain reaction (qRT-PCR). This measure reports the fold change in expression from baseline. Due to very low or undetectable baseline IFN-γ expression in many tumor biopsy samples, the fold change values calculated by qRT-PCR using the delta-delta Ct method may result in large numeric values. All values reported reflect fold change from baseline and were calculated per the qRT-PCR assay standard procedures

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=1 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=2 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=4 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=1 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD n=1 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression IFN-gamma mRNA levels: C1D1-7	11 fold change Standard Deviation 0	89 fold change Standard Deviation 132	242 fold change Standard Deviation 340	30 fold change Standard Deviation 43	—	—	—	—
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression IFN-gamma mRNA levels: C1D8-15	—	195 fold change Standard Deviation 293	239 fold change Standard Deviation 247	0 fold change Standard Deviation 0	—	—	—	—
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression IFN-gamma mRNA levels: C2D1-7	—	392 fold change Standard Deviation 617	—	33 fold change Standard Deviation 0	—	—	—	—
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression IFN-gamma mRNA levels: C2D8-15	1 fold change Standard Deviation 0	68 fold change Standard Deviation 96	2 fold change Standard Deviation 0	24 fold change Standard Deviation 0	—	—	—	—
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression IFN-gamma mRNA levels: C3D1-7	42 fold change Standard Deviation 0	83 fold change Standard Deviation 110	—	15 fold change Standard Deviation 13	—	—	—	—
Change From Baseline in Tumor Interferon-gamma (IFN-γ) Messenger RNA (mRNA) Expression IFN-gamma mRNA levels: C3D8-15	—	417 fold change Standard Deviation 487	—	1 fold change Standard Deviation 2	—	89 fold change Standard Deviation 0	4 fold change Standard Deviation 0	—

SECONDARY outcome

Timeframe: Day 2 of Cycle 1, Day 2 of Cycle 2, and Day 2 of Cycle 3.

Population: The analysis was performed on subjects from the Safety Population who had a tumor biopsy sample available for analysis at any of the specified time points. The number of subjects with available data varies by cohort and time point, and the Overall Number of Participants Analyzed for each cohort reflects the unique number of subjects in that cohort who contributed data at any time point.

To evaluate the presence of the viral vector in the tumor, biopsy samples were assessed for vector copy numbers using a quantitative polymerase chain reaction (qPCR) assay. The results are reported as the number of vector copies per 100 nanograms (ng) of deoxyribonucleic acid (DNA).

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=1 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=1 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Ad-RTS-hIL-12 Vector Copy Numbers in Tumor Biopsy Samples Day 2 Cycle 1	1100000 Vector Copies per 100 ng DNA Standard Deviation 1800000	14000000 Vector Copies per 100 ng DNA Standard Deviation 25000000	100000000 Vector Copies per 100 ng DNA	—	—	—	—	—
Ad-RTS-hIL-12 Vector Copy Numbers in Tumor Biopsy Samples Day 2 Cycle 2	—	12000000 Vector Copies per 100 ng DNA Standard Deviation 16000000	140000000 Vector Copies per 100 ng DNA	3000000 Vector Copies per 100 ng DNA	—	—	—	—
Ad-RTS-hIL-12 Vector Copy Numbers in Tumor Biopsy Samples Day 2 Cycle 3	—	100000 Vector Copies per 100 ng DNA	100000 Vector Copies per 100 ng DNA	4000000 Vector Copies per 100 ng DNA	—	—	—	—

SECONDARY outcome

Timeframe: From the first dose of study treatment for up to 1 year.

Population: Analysis of BOR was performed on all subjects who received at least one dose of study drug and were evaluable for response. Of the 26 treated patients, 15 were evaluable for Best Overall Response per RECIST v1.1. Subjects were excluded if no post-baseline tumor imaging was available. The Phase I 160 mg QD and Phase II 120 mg QOD and 80 mg QOD cohorts had no evaluable subjects at the data cutoff due to early discontinuation or pending imaging. No data were imputed

Best Overall Response (BOR) was a pre-specified secondary endpoint assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1. BOR is the best response recorded from the start of treatment until disease progression. Responses include Complete Response (CR), Partial Response (PR), Stable Disease (SD), and Progressive Disease (PD).

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=3 Participants Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=3 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Best Overall Response (BOR) by RECIST 1.1 Criteria Complete Response (CR)	0 Participants	0 Participants	0 Participants	—	0 Participants	0 Participants	—	—
Best Overall Response (BOR) by RECIST 1.1 Criteria Partial Response (PR)	0 Participants	1 Participants	0 Participants	—	1 Participants	0 Participants	—	—
Best Overall Response (BOR) by RECIST 1.1 Criteria Stable Disease (SD):	1 Participants	1 Participants	2 Participants	—	1 Participants	0 Participants	—	—
Best Overall Response (BOR) by RECIST 1.1 Criteria Progressive Disease (PD)	2 Participants	1 Participants	1 Participants	—	1 Participants	3 Participants	—	—

SECONDARY outcome

Population: The analysis was performed on the PK Population, which includes all subjects who received at least one dose of INXN-1001 and had sufficient plasma concentration data to derive reliable PK parameters.

The time to reach the maximum observed plasma concentration (Tmax) of INXN-1001 following oral administration during the first treatment cycle.

Outcome measures

Outcome measures
Measure	Phase I: 5mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=3 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=4 Participants Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=4 Participants Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=4 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD n=3 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD n=2 Participants Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Time to Maximum Plasma Concentration (Tmax) of INXN-1001 (Veledimex) in Cycle 1 Cycle 1, Day 1	4 hours Interval 2.0 to 6.0	4 hours Interval 2.0 to 6.0	4 hours Interval 4.0 to 6.0	4 hours Interval 2.0 to 6.0	3 hours Interval 2.0 to 4.0	—	4 hours Interval 4.0 to 6.0	5 hours Interval 4.0 to 6.0
Time to Maximum Plasma Concentration (Tmax) of INXN-1001 (Veledimex) in Cycle 1 Cycle 1, Day 7	4 hours Interval 1.0 to 4.0	1 hours Interval 1.0 to 2.0	4 hours Interval 1.0 to 4.0	1.5 hours Interval 1.0 to 4.0	1.5 hours Interval 1.0 to 4.0	1 hours Interval 1.0 to 2.0	1 hours Interval 1.0 to 4.0	1.5 hours Interval 1.0 to 2.0

Adverse Events

Phase I: 5mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: 20mg QD

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase 1: 100mg QD

Serious events: 1 serious events

Other events: 3 other events

Deaths: 1 deaths

Phase 1: 160mg QD

Serious events: 2 serious events

Other events: 4 other events

Deaths: 1 deaths

Phase II Group 1: 160mg QD

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase II Group 2: 160mg QOD

Serious events: 3 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase II Group 2: 120mg QOD

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Phase II Group 2: 80mg QOD

Serious events: 2 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Phase I: 5mg QD n=3 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=3 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=4 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=4 participants at risk Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=4 participants at risk Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD n=3 participants at risk Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD n=2 participants at risk Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Pancytopenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Pyrexia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Disease progression	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Septic shock	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Mental status changes	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Vascular disorders Deep vein thrombosis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Mucosal inflammation	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Immune system disorders Cytokine release syndrome	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 2/2 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Candida infection	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Cellulitis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Failure to thrive	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Encephalopathy	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Haemorrhage intracranial	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Delirium	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Vascular disorders Hypotension	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose

Other adverse events

Other adverse events
Measure	Phase I: 5mg QD n=3 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 5 mg QD for 7 days every 21 days	Phase 1: 20mg QD n=3 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 20 mg QD for 7 days every 21 days	Phase 1: 100mg QD n=3 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 100 mg QD for 7 days every 21 days	Phase 1: 160mg QD n=4 participants at risk Phase I (Dose escalation): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 1: 160mg QD n=4 participants at risk Phase II (Group 1): Ad-RTS-hIL-12 + Veledimex 160mg QD for 7 days every 21 days	Phase II Group 2: 160mg QOD n=4 participants at risk Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 160mg QOD for 14 days every 28 days	Phase II Group 2: 120mg QOD n=3 participants at risk Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 120mg QOD for 14 days every 28 days	Phase II Group 2: 80mg QOD n=2 participants at risk Phase II (Group 2): Ad-RTS-hIL-12 + Veledimex 80mg QOD for 14 days every 28 days
Investigations Liver function test abnormal	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Neutrophil count increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 2/2 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 2/2 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Neutropenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Leukopenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Coagulopathy	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Lymphadenopathy	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Lymphatic obstruction	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Iron deficiency anaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Lymphopenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Cardiac disorders Atrial fibrillation	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 2/2 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Cardiac disorders Left ventricular dysfunction	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Cardiac disorders Palpitations	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Cardiac disorders Tachycardia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Eye disorders Vision blurred	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Eye disorders Diplopia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Eye disorders Dry eye	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Nausea	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 3/3 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Vomiting	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 4/4 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Abdominal tenderness	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Constipation	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Perianal erythema	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Stomatitis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Swollen tongue	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Abdominal distension	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Ascites	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Diarrhoea haemorrhagic	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Oral pain	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Chills	66.7% 2/3 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 3/3 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 3/3 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 4/4 • Number of events 8 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 5 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Gastrointestinal disorders Pyrexia	66.7% 2/3 • Number of events 5 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 3/3 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 16 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	100.0% 4/4 • Number of events 7 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 5 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Fatigue	66.7% 2/3 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 9 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 5 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Oedema peripheral	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Asthenia	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Injection site erythema	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Chest pain	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Face oedema	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Hyperhidrosis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Injection site pain	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Injection site warmth	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Malaise	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Pain	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Secretion discharge	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Mucosal inflammation	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Generalised oedema	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Injection site swelling	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Oedema	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
General disorders Tenderness	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Cellulitis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Diverticulitis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Furuncle	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Septic shock	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Upper respiratory tract infection	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Urinary tract infection	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Fungal infection	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Gastroenteritis viral	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Infections and infestations Oral candidiasis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Injury, poisoning and procedural complications Incision site haemorrhage	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Injury, poisoning and procedural complications Renal injury	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Injury, poisoning and procedural complications Sunburn	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Alanine aminotransferase increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Aspartate aminotransferase increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 5 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Blood creatinine increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Blood lactate dehydrogenase increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Platelet count decreased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Protein total increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Troponin increased	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Urine analysis abnormal	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations White blood cell count decreased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Blood bilirubin increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Lymphocyte count decreased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Blood glucose increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Gamma-glutamyltransferase increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Urine colour abnormal	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Vitamin K decreased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Weight decreased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 5 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Investigations Weight increased	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Anorexia	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	75.0% 3/4 • Number of events 6 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Decreased appetite	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Arthralgia	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Myalgia	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Contusion	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Musculoskeletal and connective tissue disorders Rhabdomyolysis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Infected neoplasm	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Dizziness	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Headache	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Anosmia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Hypogeusia	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Spinal cord compression	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Brain oedema	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Coordination abnormal	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Dysgeusia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Nervous system disorders Syncope	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Anxiety	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Bruxism	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Confusional state	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Depression	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Agitation	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Delirium	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Insomnia	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Psychiatric disorders Somnolence	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Renal and urinary disorders Oliguria	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Renal and urinary disorders Urinary retention	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Renal and urinary disorders Urine flow decreased	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Renal and urinary disorders Hydronephrosis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Renal and urinary disorders Renal disorder	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Renal and urinary disorders Renal failure acute	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Pulmonary congestion	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Sneezing	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Wheezing	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Erythema	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	66.7% 2/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 2/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Night sweats	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Skin and subcutaneous tissue disorders Skin lesion	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Vascular disorders Hypertension	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Vascular disorders Hypotension	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	50.0% 1/2 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Vascular disorders Lymphoedema	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Vascular disorders Pallor	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Vascular disorders Hot flush	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	33.3% 1/3 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose
Endocrine disorders Hypothyroidism	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/4 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	25.0% 1/4 • Number of events 1 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/3 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose	0.00% 0/2 • Serious and non-serious adverse events were monitored from the signing of informed consent through 28 days after the last dose of study drug (up to 28 weeks). Deaths (all-cause mortality) were monitored for up to 1 year following first dose

Additional Information

Jaymes Holland Clinical Consultant

Alaunos Therapeutics, Inc

Phone: 6502732627

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60