Trial Outcomes & Findings for Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors (NCT NCT02380677)

NCT ID: NCT02380677

Last Updated: 2020-06-09

Results Overview

Determination of MTD is dependent upon number of dose limiting toxicities and significant adverse events observed.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 42 participants
• Primary outcome timeframe: 13 to 19 months
• Results posted on: 2020-06-09

Participant Flow

Participant milestones

Measure	Schedule 1 Cohort 1 CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off CRLX301	Phase 2a Expansion Cohort CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Overall Study STARTED	1	1	3	3	6	6	3	4	4	2	4	5
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	1	1	3	3	6	6	3	4	4	2	4	5

Reasons for withdrawal

Measure	Schedule 1 Cohort 1 CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off CRLX301	Phase 2a Expansion Cohort CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Overall Study Adverse Event	0	0	0	1	1	4	2	2	2	1	2	1
Overall Study Physician Decision	1	0	1	1	0	0	0	0	0	0	0	0
Overall Study Lack of Efficacy	0	1	2	0	4	1	1	2	2	0	2	1
Overall Study Withdrawal by Subject	0	0	0	0	0	0	0	0	0	1	0	3
Overall Study Other	0	0	0	1	1	1	0	0	0	0	0	0

Baseline Characteristics

Phase 1/2a Dose-Escalation Study of CRLX301 in Patients With Advanced Solid Tumors

Baseline characteristics by cohort

Measure	Schedule 1 Cohort 1 n=1 Participants CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 n=1 Participants CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 n=3 Participants CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 n=3 Participants CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 n=6 Participants CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 n=6 Participants CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 n=3 Participants CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 n=4 Participants CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 n=4 Participants CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 n=2 Participants CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 n=4 Participants CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off CRLX301	Phase 2a Expansion Cohort n=5 Participants CRLX301 75mg/m2 IV given every 3 weeks CRLX301	Total n=42 Participants Total of all reporting groups
Age, Continuous	74 years STANDARD_DEVIATION NA • n=5 Participants	43 years STANDARD_DEVIATION NA • n=7 Participants	59 years STANDARD_DEVIATION 19 • n=5 Participants	67.3 years STANDARD_DEVIATION 1.53 • n=4 Participants	63.8 years STANDARD_DEVIATION 9.79 • n=21 Participants	60.2 years STANDARD_DEVIATION 11.62 • n=8 Participants	65 years STANDARD_DEVIATION 2.65 • n=8 Participants	56 years STANDARD_DEVIATION 11.52 • n=24 Participants	54 years STANDARD_DEVIATION 12.25 • n=42 Participants	72.5 years STANDARD_DEVIATION 2.12 • n=42 Participants	60.3 years STANDARD_DEVIATION 3.1 • n=42 Participants	66.8 years STANDARD_DEVIATION 4.15 • n=42 Participants	61.8 years STANDARD_DEVIATION 10.2 • n=36 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	1 Participants n=24 Participants	2 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	16 Participants n=36 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	2 Participants n=8 Participants	0 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	5 Participants n=42 Participants	26 Participants n=36 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	1 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	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=36 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	6 Participants n=8 Participants	3 Participants n=8 Participants	4 Participants n=24 Participants	3 Participants n=42 Participants	2 Participants n=42 Participants	4 Participants n=42 Participants	3 Participants n=42 Participants	38 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 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	1 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	4 Participants n=8 Participants	3 Participants n=8 Participants	3 Participants n=24 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	4 Participants n=42 Participants	5 Participants n=42 Participants	37 Participants n=36 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	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=36 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	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Primary Site of Disease at Study Entry Bladder	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	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Primary Site of Disease at Study Entry Bone	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	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Primary Site of Disease at Study Entry Breast	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	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Primary Site of Disease at Study Entry Hepatic/liver	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=36 Participants
Primary Site of Disease at Study Entry Lung	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants
Primary Site of Disease at Study Entry Lymph nodes	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	2 Participants n=36 Participants
Primary Site of Disease at Study Entry Pancreas	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	1 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	2 Participants n=36 Participants
Primary Site of Disease at Study Entry Pleura	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Primary Site of Disease at Study Entry Skin	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	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=36 Participants
Primary Site of Disease at Study Entry Prostate	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	1 Participants n=42 Participants	1 Participants n=42 Participants	3 Participants n=42 Participants	5 Participants n=36 Participants
Primary Site of Disease at Study Entry Other (not specified)	0 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants	1 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants	1 Participants n=42 Participants	18 Participants n=36 Participants
Primary Site of Disease at Study Entry Abdomen/peritoneum	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=36 Participants
Baseline ECOG Status ECOG PS Score 0	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	1 Participants n=4 Participants	4 Participants n=21 Participants	3 Participants n=8 Participants	1 Participants n=8 Participants	1 Participants n=24 Participants	3 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants	1 Participants n=42 Participants	17 Participants n=36 Participants
Baseline ECOG Status ECOG PS Score 1	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants	2 Participants n=21 Participants	3 Participants n=8 Participants	2 Participants n=8 Participants	3 Participants n=24 Participants	1 Participants n=42 Participants	2 Participants n=42 Participants	3 Participants n=42 Participants	4 Participants n=42 Participants	25 Participants n=36 Participants
Baseline BMI (kg/m^2)	30.255 kg/m^2 STANDARD_DEVIATION NA • n=5 Participants	19.63 kg/m^2 STANDARD_DEVIATION NA • n=7 Participants	28.023 kg/m^2 STANDARD_DEVIATION 1.2871 • n=5 Participants	26.917 kg/m^2 STANDARD_DEVIATION 7.6956 • n=4 Participants	26.779 kg/m^2 STANDARD_DEVIATION 4.8762 • n=21 Participants	27.422 kg/m^2 STANDARD_DEVIATION 2.7810 • n=8 Participants	33.869 kg/m^2 STANDARD_DEVIATION 5.5301 • n=8 Participants	25.173 kg/m^2 STANDARD_DEVIATION 5.7256 • n=24 Participants	24.340 kg/m^2 STANDARD_DEVIATION 3.1519 • n=42 Participants	28.142 kg/m^2 STANDARD_DEVIATION 3.4551 • n=42 Participants	26.758 kg/m^2 STANDARD_DEVIATION 4.9670 • n=42 Participants	29.118 kg/m^2 STANDARD_DEVIATION 8.0521 • n=42 Participants	27.783 kg/m^2 STANDARD_DEVIATION 3.2805 • n=36 Participants

PRIMARY outcome

Timeframe: 13 to 19 months

Population: The phase 1 safety population were analyzed for dose limiting toxicities and treatment emergent adverse events. Treatment totals include all patients that received the specific dose at any point during the study.

Determination of MTD is dependent upon number of dose limiting toxicities and significant adverse events observed.

Outcome measures

Measure	Schedule 1 Cohort 1 n=1 Participants CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 n=1 Participants CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 n=3 Participants CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 n=3 Participants CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 n=6 Participants CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 n=6 Participants CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 n=3 Participants CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 n=4 Participants CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 n=4 Participants CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 n=2 Participants CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 n=4 Participants CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off	Phase 2a Expansion Cohort CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities At least one TEAE	1 Patients with event	1 Patients with event	3 Patients with event	3 Patients with event	6 Patients with event	6 Patients with event	3 Patients with event	4 Patients with event	4 Patients with event	2 Patients with event	4 Patients with event	—
Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities At least one Serious TEAE	0 Patients with event	1 Patients with event	3 Patients with event	3 Patients with event	1 Patients with event	3 Patients with event	1 Patients with event	2 Patients with event	1 Patients with event	1 Patients with event	0 Patients with event	—
Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities At least one DLT	0 Patients with event	0 Patients with event	0 Patients with event	0 Patients with event	0 Patients with event	2 Patients with event	0 Patients with event	0 Patients with event	0 Patients with event	0 Patients with event	0 Patients with event	—
Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities At least one severe TEAE	0 Patients with event	1 Patients with event	3 Patients with event	3 Patients with event	4 Patients with event	6 Patients with event	0 Patients with event	2 Patients with event	2 Patients with event	2 Patients with event	4 Patients with event	—
Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities At least one related TEAE	1 Patients with event	1 Patients with event	2 Patients with event	3 Patients with event	6 Patients with event	6 Patients with event	3 Patients with event	3 Patients with event	4 Patients with event	2 Patients with event	4 Patients with event	—
Number of Phase 1 Participants With Treatment Emergent Adverse Events and Dose Limiting Toxicities At least one TEAE leading to discontinuation	0 Patients with event	0 Patients with event	0 Patients with event	2 Patients with event	1 Patients with event	4 Patients with event	2 Patients with event	1 Patients with event	2 Patients with event	1 Patients with event	0 Patients with event	—

PRIMARY outcome

Timeframe: 12 months

Population: The safety population (all patients) were analyzed for dose limiting toxicities and treatment emergent adverse events. Treatment totals include all patients that received the specific dose at any point during the study.

Safety variables will include AEs, SAEs, Severe AEs, Related AEs and AEs leading to Discontinuation in phase 2a subjects.

Outcome measures

Measure	Schedule 1 Cohort 1 n=5 Participants CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off	Phase 2a Expansion Cohort CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Number of Phase 2a Participants With Adverse Events as a Measure of Safety and Tolerability At least one TEAE	5 Patients with event	—	—	—	—	—	—	—	—	—	—	—
Number of Phase 2a Participants With Adverse Events as a Measure of Safety and Tolerability At least one Serious TEAE	2 Patients with event	—	—	—	—	—	—	—	—	—	—	—
Number of Phase 2a Participants With Adverse Events as a Measure of Safety and Tolerability At least one severe TEAE	5 Patients with event	—	—	—	—	—	—	—	—	—	—	—
Number of Phase 2a Participants With Adverse Events as a Measure of Safety and Tolerability At least one related TEAE	5 Patients with event	—	—	—	—	—	—	—	—	—	—	—
Number of Phase 2a Participants With Adverse Events as a Measure of Safety and Tolerability At least one TEAE leading to discontinuation	2 Patients with event	—	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 2.5 years

Area under the concentration vs time curve of released docetaxel in blood and/or urine specimens of patients receiving at least 1 dose of CRLX301.

Outcome measures

Measure	Schedule 1 Cohort 1 n=1 Participants CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 n=1 Participants CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 n=3 Participants CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 n=3 Participants CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 n=6 Participants CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 n=6 Participants CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 n=3 Participants CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 n=4 Participants CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 n=3 Participants CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 n=3 Participants CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off	Phase 2a Expansion Cohort CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Evaluate the Pharmacokinetic (PK) Profile of CRLX301	295 ng/ml*h Standard Deviation 0	2197 ng/ml*h Standard Deviation 0	1695 ng/ml*h Standard Deviation 438	3783 ng/ml*h Standard Deviation 1054	3613 ng/ml*h Standard Deviation 1054	4639 ng/ml*h Standard Deviation 1561	1433 ng/ml*h Standard Deviation 154	2205 ng/ml*h Standard Deviation 731	2019 ng/ml*h Standard Deviation 325	2350 ng/ml*h Standard Deviation 453	—	—

SECONDARY outcome

Timeframe: 2.5 years

Population: All patients treated on study (safety population) were evaluated for overall tumor response.

Best overall tumor response will be provided per dose cohort using RECIST 1.1

Outcome measures

Measure	Schedule 1 Cohort 1 n=1 Participants CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 n=1 Participants CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 n=3 Participants CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 n=3 Participants CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 n=6 Participants CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 n=6 Participants CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 n=3 Participants CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 n=4 Participants CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 n=4 Participants CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 n=2 Participants CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 n=4 Participants CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off	Phase 2a Expansion Cohort n=5 Participants CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Percentage of Participants Stratified by Best Overall Tumor Response Complete Response	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 84.2	0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 52.2
Percentage of Participants Stratified by Best Overall Tumor Response Partial Response	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 60.2	25 percentage of participants Interval 0.6 to 80.6	0 percentage of participants Interval 0.0 to 84.2	0 percentage of participants Interval 0.0 to 60.2	20 percentage of participants Interval 0.5 to 71.6
Percentage of Participants Stratified by Best Overall Tumor Response Stable Disease	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5	66.7 percentage of participants Interval 9.4 to 99.2	100 percentage of participants Interval 29.2 to 100.0	16.7 percentage of participants Interval 0.4 to 64.1	16.7 percentage of participants Interval 0.4 to 64.1	100 percentage of participants Interval 29.2 to 100.0	75 percentage of participants Interval 19.4 to 99.4	50 percentage of participants Interval 6.8 to 93.2	50 percentage of participants Interval 1.3 to 98.7	100 percentage of participants Interval 39.8 to 100.0	40 percentage of participants Interval 5.3 to 85.3
Percentage of Participants Stratified by Best Overall Tumor Response Progressive Disease	100 percentage of participants Interval 2.5 to 100.0	100 percentage of participants Interval 2.5 to 100.0	33.3 percentage of participants Interval 0.8 to 90.6	0 percentage of participants Interval 0.0 to 70.8	66.7 percentage of participants Interval 22.3 to 95.7	16.7 percentage of participants Interval 0.4 to 64.1	0 percentage of participants Interval 0.0 to 70.8	25 percentage of participants Interval 0.6 to 80.6	25 percentage of participants Interval 0.6 to 80.6	50 percentage of participants Interval 1.3 to 98.7	0 percentage of participants Interval 0.0 to 60.2	20 percentage of participants Interval 0.5 to 71.6
Percentage of Participants Stratified by Best Overall Tumor Response Not Evaluated	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 97.5	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 45.9	0 percentage of participants Interval 0.0 to 70.8	0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 84.2	0 percentage of participants Interval 0.0 to 60.2	0 percentage of participants Interval 0.0 to 52.2

Adverse Events

Schedule 1 Cohort 1

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Schedule 1 Cohort 2

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Schedule 1 Cohort 3

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Schedule 1 Cohort 5

Serious events: 3 serious events

Other events: 3 other events

Deaths: 1 deaths

Schedule 1 Cohort 6

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Schedule 1 Cohort 7

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Schedule 2 Cohort 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Schedule 2 Cohort 2

Serious events: 2 serious events

Other events: 4 other events

Deaths: 2 deaths

Schedule 2 Cohort 3

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Schedule 2 Cohort 4

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Schedule 2 Cohort 5

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Phase 2a Expansion Cohort

Serious events: 2 serious events

Other events: 5 other events

Deaths: 1 deaths

Serious adverse events

Measure	Schedule 1 Cohort 1 n=1 participants at risk CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 n=1 participants at risk CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 n=3 participants at risk CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 n=3 participants at risk CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 n=6 participants at risk CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 n=6 participants at risk CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 n=3 participants at risk CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 n=4 participants at risk CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 n=4 participants at risk CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 n=2 participants at risk CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 n=4 participants at risk CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off CRLX301	Phase 2a Expansion Cohort n=5 participants at risk CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Infections and infestations Injection site infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Oesohageal stenosis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Pyrexia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Liver function test abnormal	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Asthenia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Urinary tract infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Renal and urinary disorders Haematuria	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.

Other adverse events

Measure	Schedule 1 Cohort 1 n=1 participants at risk CRLX301 7.5 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 2 n=1 participants at risk CRLX301 15 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 3 n=3 participants at risk CRLX301 30 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 5 n=3 participants at risk CRLX301 60 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 6 n=6 participants at risk CRLX301 75 mg/m2 IV given every 3 weeks CRLX301	Schedule 1 Cohort 7 n=6 participants at risk CRLX301 90 mg/m2 IV given every 3 weeks CRLX301	Schedule 2 Cohort 1 n=3 participants at risk CRLX301 25 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 2 n=4 participants at risk CRLX301 35 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 3 n=4 participants at risk CRLX301 45 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 4 n=2 participants at risk CRLX301 54 mg/m2 IV given weekly CRLX301	Schedule 2 Cohort 5 n=4 participants at risk CRLX301 54 mg/m2 given weekly for 3 weeks with 1 week off CRLX301	Phase 2a Expansion Cohort n=5 participants at risk CRLX301 75mg/m2 IV given every 3 weeks CRLX301
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Skin hyperpigmenation	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Vascular disorders Flushing	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Influenza like illness	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Extravasation	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Chest pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Chills	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Fatigue	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 3/3 • Number of events 8 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	83.3% 5/6 • Number of events 6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 4/6 • Number of events 9 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 4/4 • Number of events 10 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 2/2 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 4/4 • Number of events 10 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	60.0% 3/5 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Gait disturbance	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Localised oedema	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Malaise	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Flatulence	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Vomiting	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Asthenia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Glossodynia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Haemorrhoids	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Mouth ulceration	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Nausea	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 2/2 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 7 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Oral pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Oesophageal stenosis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Rash	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Paraesthesia oral	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Proctalgia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Stomatitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Anaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 2/2 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	40.0% 2/5 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Leukopenia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Leukocytosis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Neutropenia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 3/6 • Number of events 12 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 5/5 • Number of events 6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Cardiac disorders Atrial fibrillation	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Cardiac disorders Cardiac failure	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Cardiac disorders Palpitations	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Cardiac disorders Pericardial effusion	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Cardiac disorders Sinus tachycardia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Cardiac disorders Tachycardia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Ear and labyrinth disorders Ear pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Eye disorders Blepharitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Eye disorders Dry eye	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Eye disorders Episcleritis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Eye disorders Eye disorder	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Eye disorders Lacrimation increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Eye disorders Visual impairment	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Abdominal distention	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Abdominal pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 3/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Chapped lips	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Cheilitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Constipation	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 2/2 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Diarrhoea	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 3/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 3/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Dry mouth	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Dyspepsia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Gastrointestinal disorders Dysphagia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Mucosal inflammation	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Non-cardiac chest pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Oedema peripheral	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Peripheral swelling	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
General disorders Pyrexia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 3/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Hepatobiliary disorders Jaundice	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Hepatobiliary disorders candida infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations conjunctivitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Cystitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Hordeolum	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Injection site infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Lower respiratory tract infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Lung infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Oral candidiasis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Sinusitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Skin infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Upper respiratory tract infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Urinary tract infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Infections and infestations Viral infection	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Injury, poisoning and procedural complications Fall	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Injury, poisoning and procedural complications Infusion related reaction	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 4/6 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Alanine aminotransferase increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Aspartate aminotransferase increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Blood alkaline phosphatase increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Blood bilirubin increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Blood cholesterol incrased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Blood creatinine increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Blood triglycerides increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	40.0% 2/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Electrocardiogram	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Electrocardiogram QT prolonged	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Electrocardiogram abnormal	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Liver function test abnormal	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Lymphocyte count decreased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Neutrophil count decreased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Reticulocyte count increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Urine output decreased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Waist circumference increased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations Weight decreased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Investigations White blood cell count decreased	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 3/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	83.3% 5/6 • Number of events 7 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 4/4 • Number of events 9 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 2/2 • Number of events 6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Dehydration	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Failure to thrive	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Gout	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hypertriglyceridaemia	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	40.0% 2/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 3/6 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Joint swelling	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Myopathy	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	40.0% 2/5 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Seborrhoeic keratosis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders cognitive disorder	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 9 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Dizziness	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Dysgeusia	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 4/6 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 4/4 • Number of events 7 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 2/2 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Headache	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Hypoaesthesia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Lethargy	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Neuropathy peripheral	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 8 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	40.0% 2/5 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Paraesthesia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 4/6 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Peripheral motor neuropathy	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	75.0% 3/4 • Number of events 7 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Presyncope	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Restless legs syndrome	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Nervous system disorders Sciatica	100.0% 1/1 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Psychiatric disorders Agitation	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Psychiatric disorders Anxiety	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Psychiatric disorders Insomnia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Psychiatric disorders Sleep disorder	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Renal and urinary disorders Haematuria	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Renal and urinary disorders Micturition urgency	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Renal and urinary disorders Urinary incontinence	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Reproductive system and breast disorders pelvic pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 1/2 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Respiratory, thoracic and mediastinal disorders Sinus disorder	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Alopecia	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	66.7% 2/3 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	50.0% 2/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Nail bed tenderness	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Nail ridging	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Nail toxicity	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Palmar-plantar erythrodysaesthesia syndrome	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	100.0% 1/1 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	16.7% 1/6 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Vascular disorders Haematoma	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Vascular disorders Hot flush	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Vascular disorders Hypertension	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 2/6 • Number of events 2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Vascular disorders Hypotension	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Vascular disorders Orthostatic hypotension	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	33.3% 1/3 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Vascular disorders Thrombophlebitis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	25.0% 1/4 • Number of events 4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/5 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.
Blood and lymphatic system disorders Agranulocytosis	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/6 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/3 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/2 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	0.00% 0/4 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.	20.0% 1/5 • Number of events 1 • All AEs were collected occurring during the study period from the time of the first dose to the last day of the 30-day post-treatment follow-up period.

Additional Information

Manager, Clinical Operations

NewLink Genetics Corporation

Phone: 515-598-5020

Email: csmith@linkp.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60