Trial Outcomes & Findings for Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer (NCT NCT00101907)

NCT ID: NCT00101907

Last Updated: 2014-03-20

Results Overview

The number of participants who experienced at least one treatment-emergent adverse event. Additional details regarding specfic adverse events are provided in the Adverse Event section of this posting.

Recruitment status

TERMINATED

Study phase

PHASE1

Target enrollment

41 participants

Primary outcome timeframe

From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.

Results posted on

2014-03-20

Participant Flow

Participants were enrolled from 2 December 2004 through 7 March 2007. This study was designed with two parts. However, Part 2 was not conducted due to safety issues found in Part 1. Thus Part 1 is referenced as the overall study here.

Participant milestones

Participant milestones
Measure	Panitumumab + Gem/Cis Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Overall Study STARTED	8	8	6	6	11	2
Overall Study COMPLETED	6	7	5	5	6	2
Overall Study NOT COMPLETED	2	1	1	1	5	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Panitumumab + Gem/Cis Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Overall Study Adverse Event	1	0	0	0	0
Overall Study Death	0	1	0	0	3
Overall Study Physician Decision	0	0	0	1	1
Overall Study Withdrawal by Subject	1	0	1	0	1

Baseline Characteristics

Safety of AMG 706 Plus Panitumumab Plus Gemcitabine-Cisplatin in the Treatment of Patients With Advanced Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Panitumumab + Gem/Cis n=8 Participants Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=8 Participants AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis n=11 Participants AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	Total n=41 Participants Total of all reporting groups
Age, Continuous	55.5 years STANDARD_DEVIATION 12.4 • n=5 Participants	60.4 years STANDARD_DEVIATION 13.8 • n=7 Participants	56.0 years STANDARD_DEVIATION 13.3 • n=5 Participants	51.5 years STANDARD_DEVIATION 13.5 • n=4 Participants	61.1 years STANDARD_DEVIATION 8.3 • n=21 Participants	65.0 years STANDARD_DEVIATION 17.0 • n=8 Participants	57.9 years STANDARD_DEVIATION 12.0 • n=8 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	5 Participants n=21 Participants	0 Participants n=8 Participants	18 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	4 Participants n=5 Participants	2 Participants n=4 Participants	6 Participants n=21 Participants	2 Participants n=8 Participants	23 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	4 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized White or Caucasian	6 Participants n=5 Participants	7 Participants n=7 Participants	4 Participants n=5 Participants	6 Participants n=4 Participants	11 Participants n=21 Participants	2 Participants n=8 Participants	36 Participants n=8 Participants

PRIMARY outcome

Timeframe: From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days.

Population: Safety Analysis Set, composed of all participants in the AMG 706 treatment groups who received at least one dose of AMG 706 and all participants in the panitumumab-only treatment group who received at least one dose of panitumumab.

Outcome measures

Outcome measures
Measure	Panitumumab + Gem/Cis n=8 Participants Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=8 Participants AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis n=11 Participants AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Participant Incidence of Adverse Events	8 Participants	8 Participants	6 Participants	6 Participants	11 Participants	2 Participants

SECONDARY outcome

Timeframe: From enrollment until date of last follow-up visit. The median follow-up time was 24 weeks, with a range of 3 to 73 weeks.

Population: Efficacy Analysis Set, defined as defined as patients who received at least 1 dose of AMG 706 for AMG 706 treatment groups and patients who received at least 1 dose of panitumumab for the panitumumab-only treatment group.

The number of participants with a confirmed objective tumor response, defined as a complete response (CR) or partial response (PR) throughout based on modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. Any CR or PR was to be confirmed 4 to 6 weeks after the initial CR or PR.

Outcome measures

Outcome measures
Measure	Panitumumab + Gem/Cis n=8 Participants Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=8 Participants AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis n=11 Participants AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Number of Participants With an Objective Tumor Response	2 participants	0 participants	1 participants	4 participants	2 participants	1 participants

SECONDARY outcome

Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Population: The Pharmacokinetic (PK) Analysis Set consists of patients who had dosing and PK sampling times recorded on the day of PK sample collection and no significant protocol deviations that impacted the quality of the PK data (for example, sample processing errors and/or inaccurate dosing on the day of the PK sampling).

Time after dosing when maximum plasma concentration was observed for AMG 706

Outcome measures

Outcome measures
Measure	Panitumumab + Gem/Cis n=8 Participants Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=4 Participants AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=11 Participants AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Tmax	1.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 3.0	1.38 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 3.0	1.00 hours Interval 1.0 to 1.0	—

SECONDARY outcome

Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Population: PK analysis set.

The maximum observed plasma concentration after AMG 706 dosing

Outcome measures

Outcome measures
Measure	Panitumumab + Gem/Cis n=8 Participants Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 Participants AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=4 Participants AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=11 Participants AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Cmax	152 ng/mL Standard Deviation 78	186 ng/mL Standard Deviation 92	278 ng/mL Standard Deviation 90	458 ng/mL Standard Deviation 208	268 ng/mL Standard Deviation NA Standard deviation could not be calculated due to sample size of 2.	—

SECONDARY outcome

Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Population: PK Analysis set; Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.

Area under the plasma concentration-time curve from time 0 to 24 hours postdose (AUC0-24) with AMG 706. AUC0-24 was estimated using the linear/log trapezoidal method. For the BID cohort, AUC0 24 was estimated as 2 times the AUC from time 0 to 12 hours post the first daily dose (AUC0-12) using the linear/log trapezoidal method.

Outcome measures

Outcome measures
Measure	Panitumumab + Gem/Cis n=7 Participants Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=4 Participants AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=11 Participants AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
AUC0-24	1.03 μg*hr/mL Standard Deviation 0.50	1.31 μg*hr/mL Standard Deviation 0.51	2.38 μg*hr/mL Standard Deviation NA Standard deviation could not be calculated due to sample size of 2.	2.82 μg*hr/mL Standard Deviation 1.02	2.54 μg*hr/mL Standard Deviation NA Standard deviation could not be calculated due to sample size of 2.	—

SECONDARY outcome

Timeframe: Day 1, pre-dose and at 1, 3, 6,12 (BID cohort only) and 24 hours post-dose.

Population: PK analysis set. Patients with elevated AMG 706 concentrations at 24 hours were excluded from the AUC summary statistics calculations.

Area under the concentration-time curve from time 0 to infinite time (AUC0-inf) postdose with AMG 706. AUC0-inf was estimated using the linear/log trapezoidal method. AUC0-inf was not calculated for the BID cohort.

Outcome measures

Outcome measures
Measure	Panitumumab + Gem/Cis n=7 Participants Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=3 Participants AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=2 Participants AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=9 Participants AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/Cis AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/Cis AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
AUC0-inf	1.12 μg*hr/mL Standard Deviation 0.52	1.64 μg*hr/mL Standard Deviation 0.48	2.59 μg*hr/mL Standard Deviation NA Standard deviation not calculated due to sample size of 2.	3.05 μg*hr/mL Standard Deviation 1.34	—	—

Adverse Events

Panitumumab + Gem/Cis

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

50 mg QD AMG 706 + Panitumumab + Gem/Cis

Serious events: 4 serious events

Other events: 8 other events

Deaths: 0 deaths

75 mg QD AMG 706 + Panitumumab + Gem/Cis

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

100 mg QD AMG 706 + Panitumumab + Gem/Cis

Serious events: 4 serious events

Other events: 6 other events

Deaths: 0 deaths

125 mg QD AMG 706 + Panitumumab + Gem/CisEdit

Serious events: 9 serious events

Other events: 11 other events

Deaths: 0 deaths

75 mg BID AMG 706 + Panitumumab + Gem/CisEdit

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Panitumumab + Gem/Cis n=8 participants at risk Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=8 participants at risk AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 participants at risk AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 participants at risk AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/CisEdit n=11 participants at risk AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/CisEdit n=2 participants at risk AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Blood and lymphatic system disorders Anaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Angina pectoris	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac failure congestive	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiomyopathy	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Hypothyroidism	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Anal fistula	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Oesophageal perforation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Sudden death	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholecystitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Cholelithiasis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Hepatic failure	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Catheter related infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Diverticulitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sepsis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Narcotic intoxication	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Overdose	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Fluid retention	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Cerebrovascular accident	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Syncope	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Confusional state	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Respiratory failure	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Arterial thrombosis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Deep vein thrombosis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Other adverse events

Other adverse events
Measure	Panitumumab + Gem/Cis n=8 participants at risk Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m\^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m\^2 IV on Day 1 of each 3-week cycle.	50 mg QD AMG 706 + Panitumumab + Gem/Cis n=8 participants at risk AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 participants at risk AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	100 mg QD AMG 706 + Panitumumab + Gem/Cis n=6 participants at risk AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	125 mg QD AMG 706 + Panitumumab + Gem/CisEdit n=11 participants at risk AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.	75 mg BID AMG 706 + Panitumumab + Gem/CisEdit n=2 participants at risk AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m\^2 on Day 1 and Day 8, and cisplatin 75 mg/m\^2 on Day 1 of each 3-week cycle.
Hepatobiliary disorders Jaundice	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Adenoviral conjunctivitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Candidiasis	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Catheter related infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Anaemia	75.0% 6/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	36.4% 4/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Haemorrhagic diathesis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Hypocoagulable state	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Leukopenia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Lymphadenitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Neutropenia	50.0% 4/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Polycythaemia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Blood and lymphatic system disorders Thrombocytopenia	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	45.5% 5/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Atrial fibrillation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiac tamponade	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiomegaly	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Cardiomyopathy	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Mitral valve incompetence	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Pericardial effusion	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sinus bradycardia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Sinus tachycardia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Supraventricular extrasystoles	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Cardiac disorders Tachycardia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Deafness	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Ear congestion	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Ear pain	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Hearing impaired	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Hypoacusis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Middle ear effusion	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Ear and labyrinth disorders Tinnitus	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Endocrine disorders Hypothyroidism	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Conjunctivitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Diplopia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Dry eye	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Erythema of eyelid	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Eye swelling	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Eyelid oedema	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Eyelids pruritus	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Lacrimation increased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Vision blurred	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Eye disorders Visual disturbance	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal discomfort	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal distension	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	45.5% 5/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Chapped lips	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Cheilitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Constipation	37.5% 3/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	37.5% 3/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	54.5% 6/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Diarrhoea	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	81.8% 9/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dry mouth	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dyspepsia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Dysphagia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Eructation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Flatulence	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastritis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gastrooesophageal reflux disease	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gingival bleeding	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gingival disorder	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Gingival pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haematemesis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Haematochezia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Lip dry	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Nausea	75.0% 6/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	75.0% 6/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	100.0% 6/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	90.9% 10/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Rectal discharge	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Stomatitis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Toothache	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Umbilical hernia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Gastrointestinal disorders Vomiting	50.0% 4/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 4/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	54.5% 6/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Adverse drug reaction	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Application site rash	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Asthenia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Catheter site discharge	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Catheter site erythema	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Catheter site pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Catheter site related reaction	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Chest pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Crepitations	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Cyst	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Early satiety	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Extravasation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Fatigue	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	87.5% 7/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	90.9% 10/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	100.0% 2/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Generalised oedema	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Hypothermia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Impaired healing	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Infusion site reaction	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site bruising	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Injection site reaction	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Mucosal inflammation	50.0% 4/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Non-cardiac chest pain	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Oedema peripheral	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pain	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
General disorders Pyrexia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Hepatobiliary disorders Gallbladder disorder	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Cellulitis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Conjunctivitis viral	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Fungal infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Herpes zoster	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Infected sebaceous cyst	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Localised infection	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nail bed infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Nasopharyngitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Onychomycosis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Oral candidiasis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Oral fungal infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Otitis media	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Paronychia	37.5% 3/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Pneumonia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Rash pustular	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Respiratory tract infection	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Rhinitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Sinusitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tinea pedis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Tooth abscess	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Upper respiratory tract infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Urinary tract infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Infections and infestations Wound infection	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Muscle strain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Injury, poisoning and procedural complications Thermal burn	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Alanine aminotransferase increased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Aspartate aminotransferase	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Aspartate aminotransferase increased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood magnesium decreased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood phosphorus decreased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Blood potassium decreased	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Breath sounds abnormal	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Electrocardiogram QT prolonged	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Haemoglobin decreased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations International normalised ratio increased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Neutrophil count decreased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Platelet count decreased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Platelet count increased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Prothrombin time ratio increased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Investigations Weight decreased	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	45.5% 5/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Anorexia	50.0% 4/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 4/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	54.5% 6/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Appetite disorder	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Dehydration	37.5% 3/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypercreatininaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypokalaemia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	54.5% 6/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypomagnesaemia	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	37.5% 3/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	54.5% 6/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	100.0% 2/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Muscle spasms	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Myalgia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Neck pain	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Amnesia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Disturbance in attention	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dizziness	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dysarthria	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Dysgeusia	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 3/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	36.4% 4/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Facial palsy	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Headache	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Hypoaesthesia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Neuropathy peripheral	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Paraesthesia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Sinus headache	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Syncope	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Transient ischaemic attack	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Nervous system disorders Tremor	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Abnormal dreams	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Agitation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Anxiety	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Confusional state	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Depression	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	36.4% 4/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Insomnia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	37.5% 3/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	36.4% 4/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Libido decreased	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Mood altered	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Psychiatric disorders Sleep disorder	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Dysuria	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Pollakiuria	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Proteinuria	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Renal and urinary disorders Renal failure	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Breast tenderness	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Vaginal discharge	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Reproductive system and breast disorders Vaginal haemorrhage	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Asthma	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Atelectasis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	36.4% 4/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Emphysema	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Epistaxis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	36.4% 4/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Hiccups	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Lung infiltration	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Nasal ulcer	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Pulmonary hypertension	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Sinus congestion	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Respiratory, thoracic and mediastinal disorders Throat irritation	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Acne	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Alopecia	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermatitis acneiform	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	36.4% 4/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dermatitis contact	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Dry skin	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Erythema	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	100.0% 6/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Exfoliative rash	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Increased tendency to bruise	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Nail disorder	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Night sweats	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Onychoclasis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pain of skin	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Pruritus	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	83.3% 5/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	100.0% 2/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash	75.0% 6/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	62.5% 5/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	100.0% 2/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash erythematous	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	27.3% 3/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	18.2% 2/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin disorder	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin fissures	25.0% 2/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin irritation	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Surgical and medical procedures Central venous catheterisation	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Deep vein thrombosis	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Flushing	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	9.1% 1/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hot flush	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypertension	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	37.5% 3/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	66.7% 4/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	33.3% 2/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	45.5% 5/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	50.0% 1/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Hypotension	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Jugular vein thrombosis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	16.7% 1/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Phlebitis	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.
Vascular disorders Venous thrombosis limb	0.00% 0/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	12.5% 1/8 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/6 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/11 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.	0.00% 0/2 • From the first dose of any study treatment until 30 days after the last dose of study treatment, up to a maximum of 509 days. The table of Other Adverse Events summarizes the most frequent non-serious occurrences of adverse events.

Additional Information

Study Director

Amgen Inc.

Phone: 866-572-6436

Results disclosure agreements

Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results aftercompletion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
Publication restrictions are in place

Restriction type: OTHER