Trial Outcomes & Findings for A Phase 1 Study of Dexanabinol in Patients With Advanced Solid Tumours (NCT NCT01489826)

Last Updated: 2017-02-09

Results Overview

Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the maximum tolerated dose (MTD) (highest dose it is safe to give patients) or alternatively the maximum administered dose (MAD). 3 patients will be enrolled to a cohort to assess each dose level. Dose escalation to a cohort of 3 new patients will occur when all patients in the previous cohort have completed the first cycle i.e. the first 3 doses followed by observation through to Day 22, and no DLT has occurred. Upon occurrence of the first DLT within a cohort, an additional 3 patients were to be added to that cohort. For a six patient cohort, all 6 patients were to have completed their first dexanabinol treatment cycle with no more than 1 DLT before dose escalation to the next cohort. If 2 or more DLTs occur in a cohort, the next lower dose level will be declared the MTD. DLTs will be graded for severity based on the National Cancer Institute (NCI) Common Terminology Criteria version 4.03.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

40 participants

Primary outcome timeframe

Each patient will be followed for 22 days

Results posted on

2017-02-09

Participant Flow

Participant milestones

Participant milestones
Measure	Dexanabinol 2 mg/kg Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Overall Study STARTED	3	3	3	7	3	3	9	3	6
Overall Study COMPLETED	3	3	3	7	3	3	9	3	6
Overall Study NOT COMPLETED	0	0	0	0	0	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Phase 1 Study of Dexanabinol in Patients With Advanced Solid Tumours

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dexanabinol Dose Escalation - Cohort 1 n=3 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Dose Escalation - Cohort 2 n=3 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Dose Escalation - Cohort 3 n=3 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Dose Escalation - Cohort 4 n=7 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Dose Escalation - Cohort 5 n=3 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Dose Escalation - Cohort 6 n=3 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Dose Escalation - Cohort 7 n=9 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Dose Escalation - Cohort 8 n=3 Participants Open label, dose escalation phase to assess tolerability and pharmacokinetics of dexanabinol in patients with advanced tumours	Dexanabinol Expansion Phase n=6 Participants Open label, expansion phase to assess pharmacodynamics of dexanabinol in patients with advanced tumours at the MTD/MAD (30 mg/kg)	Total n=40 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	0 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants	7 Participants n=7 Participants	3 Participants n=31 Participants	3 Participants n=30 Participants	9 Participants n=3 Participants	3 Participants n=6 Participants	6 Participants n=114 Participants	38 Participants
Age, Categorical >=65 years	2 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants	0 Participants n=7 Participants	0 Participants n=31 Participants	0 Participants n=30 Participants	0 Participants n=3 Participants	0 Participants n=6 Participants	0 Participants n=114 Participants	2 Participants
Age, Continuous	66.7 years STANDARD_DEVIATION 10.21 • n=99 Participants	61.3 years STANDARD_DEVIATION 7.64 • n=107 Participants	69.0 years STANDARD_DEVIATION 11.14 • n=206 Participants	57.9 years STANDARD_DEVIATION 7.27 • n=7 Participants	52.3 years STANDARD_DEVIATION 5.51 • n=31 Participants	62.0 years STANDARD_DEVIATION 13.11 • n=30 Participants	64.6 years STANDARD_DEVIATION 6.91 • n=3 Participants	63.7 years STANDARD_DEVIATION 12.70 • n=6 Participants	56.3 years STANDARD_DEVIATION 12.75 • n=114 Participants	61.2 years STANDARD_DEVIATION 9.69
Gender Female	1 Participants n=99 Participants	1 Participants n=107 Participants	0 Participants n=206 Participants	2 Participants n=7 Participants	1 Participants n=31 Participants	1 Participants n=30 Participants	0 Participants n=3 Participants	2 Participants n=6 Participants	4 Participants n=114 Participants	12 Participants
Gender Male	2 Participants n=99 Participants	2 Participants n=107 Participants	3 Participants n=206 Participants	5 Participants n=7 Participants	2 Participants n=31 Participants	2 Participants n=30 Participants	9 Participants n=3 Participants	1 Participants n=6 Participants	2 Participants n=114 Participants	28 Participants

PRIMARY outcome

Timeframe: Each patient will be followed for 22 days

Population: Patients will be sequentially assigned to increasing doses of Dexanabinol, to establish the MTD (highest dose it is safe to give patients) or alternatively the Maximum Administered Dose(MAD). DLT evaluation in 3 to 6 patients at end of 1 treatment cycle

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=7 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=9 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=3 Participants Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase n=6 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Number of Patients Experiencing Dose Limiting Toxicity (DLT)	0 Number of patients with DLT	0 Number of patients with DLT	0 Number of patients with DLT	1 Number of patients with DLT	0 Number of patients with DLT	0 Number of patients with DLT	0 Number of patients with DLT	2 Number of patients with DLT	0 Number of patients with DLT

SECONDARY outcome

Timeframe: Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Population: Concentrations of dexanabinol were not reported for some patients on Days 1 or 8 (including all patients in the 6 mg/kg arm) because the bioanalytical assay, in these instances, was not appropriately validated on the day of the assay. For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.

Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 1.

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=2 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=1 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=4 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=2 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=7 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=1 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 1	2620 ng.h/mL Geometric Coefficient of Variation 33.9	6520 ng.h/mL Geometric Coefficient of Variation 0	25000 ng.h/mL Geometric Coefficient of Variation 53.3	27500 ng.h/mL Geometric Coefficient of Variation 5.99	46900 ng.h/mL Geometric Coefficient of Variation 41.9	110000 ng.h/mL Geometric Coefficient of Variation 59.9	219000 ng.h/mL Geometric Coefficient of Variation 0	—	—

SECONDARY outcome

Timeframe: Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Mean Cmax of Dexanabinol on Cycle 1 Day 1

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=2 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=4 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=3 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=7 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=1 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 1	606 ng/mL Geometric Coefficient of Variation 20.9	1580 ng/mL Geometric Coefficient of Variation 0.895	6950 ng/mL Geometric Coefficient of Variation 76.8	7790 ng/mL Geometric Coefficient of Variation 24.8	13000 ng/mL Geometric Coefficient of Variation 27.4	28800 ng/mL Geometric Coefficient of Variation 62.3	45600 ng/mL Geometric Coefficient of Variation 0	—	—

SECONDARY outcome

Timeframe: 30 +/-3 days from the end of the last infusion

Population: The numbers represent the total number of AEs per group. Refer to AE tables for specific information.

AEs will be graded according to the NCI CTCAE v4.03 for cancer clinical trials

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=7 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=9 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=3 Participants Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase n=6 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Number of Adverse Events (AEs)	68 Events	31 Events	26 Events	90 Events	64 Events	60 Events	85 Events	47 Events	62 Events

SECONDARY outcome

Timeframe: At Screening and after every 2 cycles of treatment (+/-1 week)

Population: Patients included in this analysis were from the 'Efficacy population', defined as those with a baseline and at least one post-baseline assessment of efficacy.

Tumour response evaluation using RECIST 1.1. (Assessment by CT scan or MRI).

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=6 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=6 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=2 Participants Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase n=6 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Progression Free Survival	133.0 Days Interval 100.0 to 267.0	70.0 Days Interval 36.0 to Upper inter-quartile range could not be calculated due to censored value.	37.0 Days Interval 35.0 to Upper inter-quartile range could not be calculated due to censored value.	43.0 Days Interval 36.0 to 51.0	176.0 Days Interval 86.0 to 176.0	293.0 Days Interval 293.0 to 293.0	40.5 Days Interval 36.0 to 66.0	NA Days Interval 43.0 to Median could not be calculated as there were only two values. Upper inter-quartile range could not be calculated due to censored value.	37.0 Days Interval 36.0 to 49.0

SECONDARY outcome

Timeframe: Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Geometric mean AUC of Dexanabinol (0-infinity) on Cycle 1 Day 8.

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=2 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=2 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=5 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=3 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=7 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=1 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Area Under Curve (AUC) of Dexanabinol on Cycle 1 Day 8	2600 ng.h/mL Geometric Coefficient of Variation 31.5	5140 ng.h/mL Geometric Coefficient of Variation 2.39	29500 ng.h/mL Geometric Coefficient of Variation 47.2	45700 ng.h/mL Geometric Coefficient of Variation 40.4	96500 ng.h/mL Geometric Coefficient of Variation 67.2	145000 ng.h/mL Geometric Coefficient of Variation 0	—	—	—

SECONDARY outcome

Timeframe: Cycle 1- Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Population: This analysis was performed on all patients who received study drug and for whom PK samples were obtained (the PK analysis population). For the purposes of the PK analysis, the results from the expansion phase arm were combined with the 30 mg/kg arm.

Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 1.

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=6 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=14 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=3 Participants Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Area Under Curve (AUC) of Cremophor on Cycle 1 Day 1	NA µL.h/mL Geometric Coefficient of Variation NA Geometric mean could not be calculated, as too many values were below the level of quantification.	NA µL.h/mL Geometric Coefficient of Variation NA Geometric mean could not be calculated, as too many values were below the level of quantification.	10.3 µL.h/mL Geometric Coefficient of Variation 101	46.2 µL.h/mL Geometric Coefficient of Variation 69.9	29.5 µL.h/mL Geometric Coefficient of Variation 64.0	92.4 µL.h/mL Geometric Coefficient of Variation 40.5	120 µL.h/mL Geometric Coefficient of Variation 39.1	152 µL.h/mL Geometric Coefficient of Variation 75.8	—

SECONDARY outcome

Timeframe: Cycle 1- Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Geometric mean AUC of Cremophor (0-27hour) on Cycle 1 Day 8.

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=5 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=14 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=1 Participants Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Area Under Curve (AUC) of Cremophor on Cycle 1 Day 8	NA µL.h/mL Geometric Coefficient of Variation NA Geometric mean could not be calculated, as too many values were below the level of quantification.	3.15 µL.h/mL Geometric Coefficient of Variation 287	14.8 µL.h/mL Geometric Coefficient of Variation 50.1	43.6 µL.h/mL Geometric Coefficient of Variation 40.0	29.8 µL.h/mL Geometric Coefficient of Variation 88.3	97.1 µL.h/mL Geometric Coefficient of Variation 37.0	146 µL.h/mL Geometric Coefficient of Variation 54.9	138 µL.h/mL Geometric Coefficient of Variation 0	—

SECONDARY outcome

Timeframe: Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Mean Cmax of Dexanabinol on Cycle 1 Day 8

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=2 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=2 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=5 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=3 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=7 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=1 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Maximum Concentration (Cmax) of Dexanabinol Cycle 1 Day 8	705 ng/mL Geometric Coefficient of Variation 2.01	1410 ng/mL Geometric Coefficient of Variation 12.6	8600 ng/mL Geometric Coefficient of Variation 58.3	9560 ng/mL Geometric Coefficient of Variation 49.6	14600 ng/mL Geometric Coefficient of Variation 44.0	27800 ng/mL Geometric Coefficient of Variation 56.7	34900 ng/mL Geometric Coefficient of Variation 0	—	—

SECONDARY outcome

Timeframe: Cycle1 - Day 1: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Mean Cmax of Cremophor on Cycle 1 Day 1

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=6 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=14 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=3 Participants Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 1	NA µL/mL Geometric Coefficient of Variation NA Geometric mean could not be calculated, as too many values were below the level of quantification.	NA µL/mL Geometric Coefficient of Variation NA Geometric mean could not be calculated, as too many values were below the level of quantification.	1.30 µL/mL Geometric Coefficient of Variation 21.2	3.42 µL/mL Geometric Coefficient of Variation 46.9	2.72 µL/mL Geometric Coefficient of Variation 11.0	7.78 µL/mL Geometric Coefficient of Variation 33.3	8.49 µL/mL Geometric Coefficient of Variation 33.3	11.8 µL/mL Geometric Coefficient of Variation 37.5	—

SECONDARY outcome

Timeframe: Cycle1 - Day 8: pre-dose (0h); 1, 2, 3 h post start of infusion; 5, 10, 15, 30 min post-end infusion; 1, 2, 3, 4, 6, 8, 10 and 24 h post-end infusion.

Mean Cmax of Cremophor on Cycle 1 Day 8

Outcome measures

Outcome measures
Measure	Dexanabinol 2 mg/kg n=3 Participants Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 Participants Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 Participants Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=5 Participants Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 Participants Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 Participants Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=14 Participants Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=1 Participants Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Maximum Concentration (Cmax) of Cremophor Cycle 1 Day 8	NA µL/mL Geometric Coefficient of Variation NA Geometric mean could not be calculated, as too many values were below the level of quantification.	0.754 µL/mL Geometric Coefficient of Variation 44.7	1.69 µL/mL Geometric Coefficient of Variation 168	2.99 µL/mL Geometric Coefficient of Variation 34.4	2.22 µL/mL Geometric Coefficient of Variation 34.2	8.15 µL/mL Geometric Coefficient of Variation 6.51	9.91 µL/mL Geometric Coefficient of Variation 31.3	10.1 µL/mL Geometric Coefficient of Variation 0	—

Adverse Events

Dexanabinol 2 mg/kg

Serious events: 3 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexanabinol 3 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexanabinol 6 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexanabinol 12 mg/kg

Serious events: 2 serious events

Other events: 7 other events

Deaths: 0 deaths

Dexanabinol 15 mg/kg

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexanabinol 22 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexanabinol 30 mg/kg

Serious events: 5 serious events

Other events: 9 other events

Deaths: 0 deaths

Dexanabinol 36 mg/kg

Serious events: 1 serious events

Other events: 3 other events

Deaths: 0 deaths

Dexanabinol Expansion Phase

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Dexanabinol 2 mg/kg n=3 participants at risk Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 participants at risk Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 participants at risk Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=7 participants at risk Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 participants at risk Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 participants at risk Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=9 participants at risk Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=3 participants at risk Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase n=6 participants at risk Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Renal and urinary disorders Renal inpairment	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Lower respiratory tract infection	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Upper gastrointestinal haemorrhage	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Pain	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Immune system disorders hypersensitivity	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	22.2% 2/9 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Cardiac disorders Sinus tachycardia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Constipation	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Oesophageal haemorrhage	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Chest pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders General physical health deterioration	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Malaise	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Oedema peripheral	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Arthritis bacterial	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Urosepsis	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Injury, poisoning and procedural complications Hip fracture	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Metabolism and nutrition disorders Dehydration	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Altered state of conciousness	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Hemiparesis	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Somnolence	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Psychiatric disorders Confusional state	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.

Other adverse events

Other adverse events
Measure	Dexanabinol 2 mg/kg n=3 participants at risk Dexanabinol 2 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 3 mg/kg n=3 participants at risk Dexanabinol 3 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 6 mg/kg n=3 participants at risk Dexanabinol 6 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 12 mg/kg n=7 participants at risk Dexanabinol 12 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 15 mg/kg n=3 participants at risk Dexanabinol 15 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 22 mg/kg n=3 participants at risk Dexanabinol 22 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 30 mg/kg n=9 participants at risk Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol 36 mg/kg n=3 participants at risk Dexanabinol 36 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)	Dexanabinol Expansion Phase n=6 participants at risk Dexanabinol 30 mg/kg formulated in cremophor/ethanol, administered once weekly intravenously (i.v.)
Gastrointestinal disorders Nausea	33.3% 1/3 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 12 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	22.2% 2/9 • Number of events 7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	100.0% 3/3 • Number of events 5 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Fatigue	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	57.1% 4/7 • Number of events 9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	22.2% 2/9 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Diarrhoea	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 3/9 • Number of events 10 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 2/6 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Vomiting	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 5 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Constipation	66.7% 2/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Lower respiratory tract infection	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea	66.7% 2/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Blood and lymphatic system disorders Anaemia	66.7% 2/3 • Number of events 10 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 8 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 2/6 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Metabolism and nutrition disorders Decreased appetite	66.7% 2/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Somnolence	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 3/9 • Number of events 12 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 5 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 2/6 • Number of events 10 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Oedema peripheral	66.7% 2/3 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Lethargy	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 2/6 • Number of events 6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Investigations ALT increased	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 12 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Dizziness	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 3/9 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Dyspepsia	66.7% 2/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Chest pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Investigations AST increased	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 12 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Investigations Blood alkaline phosphatase increased	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Respiratory, thoracic and mediastinal disorders Cough	66.7% 2/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Skin and subcutaneous tissue disorders Dry skin	66.7% 2/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Skin and subcutaneous tissue disorders Rash	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	22.2% 2/9 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Dry mouth	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 2/6 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Pyrexia	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Oral candidiasis	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 5 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Investigations Weight decreased	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	66.7% 2/3 • Number of events 5 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Headache	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Nervous system disorders Hypoaesthesia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Vascular disorders Hot flush	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	42.9% 3/7 • Number of events 7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Vascular disorders Flushing	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Vascular disorders Hypotension	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
General disorders Chills	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Psychiatric disorders Depressed mood	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Psychiatric disorders Insomnia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Investigations Blood magnesium decreased	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Investigations Neutrophil count increased	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	28.6% 2/7 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Respiratory, thoracic and mediastinal disorders Productive cough	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Respiratory, thoracic and mediastinal disorders Wheezing	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Eye disorders Vision blurred	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	22.2% 2/9 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Mouth ulceration	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Hepatobiliary disorders Hepatic pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	11.1% 1/9 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	14.3% 1/7 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 2/6 • Number of events 3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 4 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Cellulitis	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Nasopharyngitis	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/6 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Infections and infestations Tooth abscess	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.
Gastrointestinal disorders Abdominal Pain	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	33.3% 1/3 • Number of events 2 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/7 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/9 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	0.00% 0/3 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.	16.7% 1/6 • Number of events 1 • Adverse events were captured from the day of the first dose of study drug (cycle 1 day 1) through to the final study visit (30 days +/- 3 days) after discontinuation of study drug.

Additional Information

Clinical Operations Manager

e-Therapeutics plc

Phone: +44 1993 880000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee There is an agreement between the Principal Investigator and the Sponsor (or is agents) that restricts the PIs rights to discuss or publish trial results after the trial is completed.
Publication restrictions are in place

Restriction type: OTHER