Trial Outcomes & Findings for Study to Evaluate Motesanib With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC) (NCT NCT00094835)

Last Updated: 2016-03-24

Results Overview

The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

51 participants

Primary outcome timeframe

Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Results posted on

2016-03-24

Participant Flow

Participants were enrolled from 18 January 2005 through 25 September 2006

Participant milestones

Participant milestones
Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Overall Study STARTED	9	11	7	5	7	6	6
Overall Study Treated With Motesanib	6	11	6	4	7	5	6
Overall Study COMPLETED	5	8	4	4	3	3	4
Overall Study NOT COMPLETED	4	3	3	1	4	3	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Overall Study Physician Decision	1	0	0	0	0	1	0
Overall Study Withdrawal by Subject	0	0	0	0	0	0	1
Overall Study Lost to Follow-up	0	0	0	0	1	0	0
Overall Study Death	1	0	0	0	1	0	0
Overall Study Non-compliance	1	2	2	0	2	2	1
Overall Study Other	1	1	1	1	0	0	0

Baseline Characteristics

Study to Evaluate Motesanib With or Without Carboplatin/Paclitaxel or Panitumumab in the Treatment of Patients With Advanced Non-Small Cell Lung Cancer (NSCLC)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD n=6 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=11 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=6 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=7 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=5 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Total n=45 Participants Total of all reporting groups
Age, Continuous	67.8 years STANDARD_DEVIATION 7.8 • n=5 Participants	55.7 years STANDARD_DEVIATION 12.7 • n=7 Participants	64.5 years STANDARD_DEVIATION 6.1 • n=5 Participants	57.5 years STANDARD_DEVIATION 9.9 • n=4 Participants	64.0 years STANDARD_DEVIATION 9.6 • n=21 Participants	51.6 years STANDARD_DEVIATION 14.6 • n=10 Participants	59.0 years STANDARD_DEVIATION 5.5 • n=115 Participants	59.9 years STANDARD_DEVIATION 10.8 • n=6 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	0 Participants n=4 Participants	5 Participants n=21 Participants	1 Participants n=10 Participants	3 Participants n=115 Participants	16 Participants n=6 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	7 Participants n=7 Participants	3 Participants n=5 Participants	4 Participants n=4 Participants	2 Participants n=21 Participants	4 Participants n=10 Participants	3 Participants n=115 Participants	29 Participants n=6 Participants
Race/Ethnicity, Customized White or Caucasian	6 participants n=5 Participants	11 participants n=7 Participants	5 participants n=5 Participants	4 participants n=4 Participants	6 participants n=21 Participants	4 participants n=10 Participants	5 participants n=115 Participants	41 participants n=6 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	1 participants n=21 Participants	0 participants n=10 Participants	1 participants n=115 Participants	2 participants n=6 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	0 participants n=7 Participants	1 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants	1 participants n=10 Participants	0 participants n=115 Participants	2 participants n=6 Participants

PRIMARY outcome

Timeframe: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Population: The pharmacokinetic (PK) population consisted of all consented patients who received motesanib and had evaluable pharmacokinetic data and did not have significant protocol deviations that affected the data or key-dosing information that was missing.

The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 1. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=4 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=9 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=6 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Time to Maximum Plasma Concentration of Motesanib (Tmax) for Cycle 1	1.0 hours Interval 0.5 to 1.0	0.75 hours Interval 0.5 to 2.0	1.0 hours Interval 0.5 to 6.0	0.75 hours Interval 0.25 to 1.0	1.5 hours Interval 0.5 to 4.0	0.58 hours Interval 0.5 to 1.0	1.0 hours Interval 1.0 to 4.0

PRIMARY outcome

Timeframe: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Population: PK population

The maximal observed plasma concentration of motesanib after a single dose dose in Cycle 1. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=4 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=9 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=6 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 1	444 ng/mL Standard Deviation 130	158 ng/mL Standard Deviation 55	525 ng/mL Standard Deviation 250	448 ng/mL Standard Deviation 112	328 ng/mL Standard Deviation 214	198 ng/mL Standard Deviation 55	360 ng/mL Standard Deviation 243

PRIMARY outcome

Timeframe: Cycle 1, Day 3 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours postdose.

Population: PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for the Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD treatment group for which the sample size was smaller than 3.

The terminal-phase elimination half-life (t1/2,z) of motesanib was calculated as ln(2)/λz. The terminal elimination rate constant (λz) was determined by linear regression of the natural logarithms of at least the last 3 measurable concentrations during the terminal phase. For the 75 mg BID cohorts, t1/2,z is reported for the first daily dose.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=4 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=7 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=6 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 1	7.57 hours Standard Deviation 2.60	7.34 hours Standard Deviation 2.07	5.33 hours Standard Deviation 1.05	5.77 hours Standard Deviation 1.45	6.47 hours Standard Deviation 2.31	8.28 hours Standard Deviation 2.62	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Area under the plasma concentration-time curve for motesanib in Cycle 1 calculated using the using the linear/log trapezoidal method. AUC from time zero to infinity (AUC0-inf) is reported for the 50 and 125 mg QD cohorts and AUC from time 0 to 24 hours post-dose (AUC0-24) is reported for the 75 mg BID cohort, where AUC0-24 is the sum of AUC0-12 for the first and second daily dose.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=4 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=7 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=5 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Area Under the Plasma Concentration-time Curve for Motesanib in Cycle 1	3.23 μg*hr/mL Standard Deviation 1.83	0.971 μg*hr/mL Standard Deviation 0.300	3.21 μg*hr/mL Standard Deviation 1.12	2.91 μg*hr/mL Standard Deviation 1.01	1.74 μg*hr/mL Standard Deviation 0.63	2.04 μg*hr/mL Standard Deviation 1.06	—

PRIMARY outcome

Timeframe: Cycle 1, Day 3, 24 hours post-dose

The trough plasma concentration for motesanib at 24 hours postdose in Cycle 1. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=4 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=9 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=5 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 1	32.5 ng/mL Standard Deviation 21.5	9.12 ng/mL Standard Deviation 4.17	26.5 ng/mL Standard Deviation 16.8	56.7 ng/mL Standard Deviation 27.4	14.0 ng/mL Standard Deviation 11.7	56.8 ng/mL Standard Deviation 21.1	—

PRIMARY outcome

Timeframe: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Population: PK population

The time after dosing that the maximal plasma concentration of motesanib was observed in Cycle 2. For the 75 mg BID cohorts, Tmax is reported for the first daily dose.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=4 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=9 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=6 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Time to Maximum Plasma Concentration of Motesanib (Tmax) in Cycle 2	0.75 hours Interval 0.25 to 2.0	1.5 hours Interval 1.0 to 2.0	1.0 hours Interval 0.5 to 4.0	0.63 hours Interval 0.25 to 4.0	1.0 hours Interval 0.5 to 2.0	1.0 hours Interval 0.5 to 2.0	2.0 hours Interval 0.5 to 2.0

PRIMARY outcome

Timeframe: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Population: PK population

The maximal observed plasma concentration of motesanib in Cycle 2, after multiple doses. For the 75 mg BID cohorts, Cmax is reported for the first daily dose.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=4 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=9 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=6 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Maximum Observed Plasma Concentration of Motesanib (Cmax) in Cycle 2	672 ng/mL Standard Deviation 336	148 ng/mL Standard Deviation 25	748 ng/mL Standard Deviation 701	390 ng/mL Standard Deviation 319	265 ng/mL Standard Deviation 190	242 ng/mL Standard Deviation 153	651 ng/mL Standard Deviation 605

PRIMARY outcome

Timeframe: Cycle 2, Day 1 at predose, 15 and 30 min, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Population: PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for three treatment groups for which the sample size was smaller than 3.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=5 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=5 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Estimated Terminal-phase Half-life (t1/2,z) of Motesanib in Cycle 2	—	6.41 hours Standard Deviation 2.08	6.36 hours Standard Deviation 1.70	7.08 hours Standard Deviation 0.35	4.90 hours Standard Deviation 1.21	—	—

PRIMARY outcome

Timeframe: Cycle 2, Day 1 at predose, 15 and 30 minutes, and at 1, 2, 4, 6, 10 (QD cohorts only), and 24 hours post-dose.

Population: PK Population. Participants with elevated motesanib concentrations at 24 hours were excluded from the calculations. Summary results are not presented for two treatment groups for which the sample size was smaller than 3.

Area under the plasma concentration-time curve from time 0 to 24 hours post-dose (AUC0-24) for motesanib in Cycle 2 calculated using the using the linear/log trapezoidal method. For the 75 mg BID cohort AUC0-24 is the sum of AUC0-12 for the first and second daily dose.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=5 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=5 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=5 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Area Under the Plasma Concentration-time Curve From Time 0 to 24 Hours Post-dose for Motesanib in Cycle 2	3.16 μg*hr/mL Standard Deviation 1.20	4.50 μg*hr/mL Standard Deviation 2.62	3.11 μg*hr/mL Standard Deviation 2.38	1.26 μg*hr/mL Standard Deviation 0.61	3.92 μg*hr/mL Standard Deviation 2.65	—	—

PRIMARY outcome

Timeframe: Cycle 2, Day 1, 24 hours post-dose

The trough plasma concentration for motesanib at 24 hours postdose in Cycle 2. For the 75 BID cohort, C24 is the observed concentration at 24 hours (ie, after the second daily dose).

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=3 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=5 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=5 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=3 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=5 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Trough Plasma Concentration at 24 Hours Post-dose (C24) for Motesanib in Cycle 2	45.1 ng/mL Standard Deviation 37.9	43.4 ng/mL Standard Deviation 44.8	45.4 ng/mL Standard Deviation 35.9	10.4 ng/mL Standard Deviation 5.3	61.1 ng/mL Standard Deviation 72.6	—	—

SECONDARY outcome

Timeframe: After 9 weeks of treatment (at the end of Cycle 3)

Population: Efficacy analysis set, composed of all enrolled participants who received at least one dose of motesanib in treatment arms 1-3 or at least one dose of motesanib with one dose of panitumumab in treatmnt arms 4-7.

Confirmed objective tumor response defined as a complete response (CR) or partial response (PR) using modified Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. Tumor response was evaluated by computed tomography (CT) scan or magnetic resonance imaging (MRI). Responding disease (CR or PR) was confirmed no less than 4 weeks after the criteria for response were first met. A complete response defined as the disappearance of all target lesions and all non-target lesions, no new lesions and normalization of tumor marker level. Partial response defined as either the disappearance of all target lesions and the persistence of one or more non-target lesion(s) or/and maintenance of tumor marker level above the normal limits, or, at least a 30% decrease in the sum of the longest diamer (LD) of target lesions, taking as reference the baseline sum LD and no new lesions and/or unequivocal progression of existing non-target lesions.

Outcome measures

Outcome measures
Measure	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=7 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=11 Participants Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=6 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=4 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=5 Participants Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 Participants Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Percentage of Participants With an Overall Objective Response	0 Percentage of participants	33 Percentage of participants	18 Percentage of participants	0 Percentage of participants	0 Percentage of participants	0 Percentage of participants	17 Percentage of participants

Adverse Events

Paclitaxel/Carboplatin + Motesanib 50 mg QD

Serious events: 5 serious events

Other events: 6 other events

Deaths: 0 deaths

Paclitaxel/Carboplatin + Motesanib 125 mg QD

Serious events: 2 serious events

Other events: 11 other events

Deaths: 0 deaths

Paclitaxel/Carboplatin + Motesanib 75 mg BID

Serious events: 3 serious events

Other events: 6 other events

Deaths: 0 deaths

Panitumumab + Motesanib 50 mg QD

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Panitumumab + Motesanib 125 mg QD

Serious events: 1 serious events

Other events: 7 other events

Deaths: 0 deaths

Panitumumab + Motesanib 75 mg BID

Serious events: 4 serious events

Other events: 5 other events

Deaths: 0 deaths

Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD

Serious events: 2 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD n=6 participants at risk Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=11 participants at risk Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=6 participants at risk Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=4 participants at risk Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=7 participants at risk Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=5 participants at risk Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 participants at risk Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Blood and lymphatic system disorders Febrile neutropenia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Cardiac disorders Atrial fibrillation	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Endocrine disorders Adrenal insufficiency	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Diarrhoea	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Nausea	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Pancreatitis	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Vomiting	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Fatigue	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Non-cardiac chest pain	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Pyrexia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Pneumonia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Staphylococcal sepsis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Urinary tract infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hypovolaemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Non-small cell lung cancer	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Cognitive disorder	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Encephalopathy	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Vocal cord paralysis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Confusional state	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Mental status changes	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Renal failure acute	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea exacerbated	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Hypoxia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Hypotension	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Orthostatic hypotension	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.

Other adverse events

Other adverse events
Measure	Paclitaxel/Carboplatin + Motesanib 50 mg QD n=6 participants at risk Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 125 mg QD n=11 participants at risk Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Paclitaxel/Carboplatin + Motesanib 75 mg BID n=6 participants at risk Chemotherapy naïve participants received paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 50 mg QD n=4 participants at risk Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 125 mg QD n=7 participants at risk Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Motesanib 75 mg BID n=5 participants at risk Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.	Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD n=6 participants at risk Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m\^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
Immune system disorders Hypersensitivity	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Candidiasis	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Cystitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Hypertension	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	45.5% 5/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	57.1% 4/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	60.0% 3/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Escherichia bacteraemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Hypotension	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Orthostatic hypotension	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Phlebitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Blood and lymphatic system disorders Anaemia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Blood and lymphatic system disorders Leukopenia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Blood and lymphatic system disorders Neutropenia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Blood and lymphatic system disorders Thrombocytopenia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Cardiac disorders Atrial fibrillation	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Cardiac disorders Conduction disorder	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Cardiac disorders Sinus tachycardia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Cardiac disorders Tachycardia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Ear and labyrinth disorders Deafness	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Ear and labyrinth disorders Ear discomfort	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Eye disorders Conjunctivitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Eye disorders Diplopia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Eye disorders Dry eye	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Eye disorders Vision blurred	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Abdominal discomfort	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Abdominal distension	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Abdominal pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Abdominal pain lower	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Ascites	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Change of bowel habit	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Chapped lips	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Colitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Constipation	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Diarrhoea	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	63.6% 7/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	100.0% 6/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	71.4% 5/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	60.0% 3/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	83.3% 5/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Dyspepsia	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Dysphagia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Flatulence	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Gastrointestinal pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Gingival pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Gingival ulceration	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Hyperchlorhydria	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Inguinal hernia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Mouth ulceration	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Nausea	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	54.5% 6/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	83.3% 5/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	42.9% 3/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Odynophagia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Oesophagitis	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Oral pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Stomatitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	42.9% 3/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Gastrointestinal disorders Vomiting	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	36.4% 4/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	83.3% 5/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	80.0% 4/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Adverse drug reaction	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Chest discomfort	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Chest pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Chills	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Early satiety	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Fatigue	83.3% 5/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	72.7% 8/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 2/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	85.7% 6/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	100.0% 5/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	83.3% 5/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Hypothermia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Infusion site pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Irritability	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Localised oedema	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Mucosal inflammation	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Non-cardiac chest pain	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Oedema	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Oedema peripheral	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Pyrexia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	60.0% 3/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
General disorders Temperature intolerance	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Hepatobiliary disorders Cholecystitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Eye infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Folliculitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Fungal infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Gastroenteritis	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Herpes simplex	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Infected cyst	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Infection	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Liver abscess	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Lymph gland infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Oral candidiasis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Oral infection	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Paronychia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Respiratory tract infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Rhinitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Sinusitis	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Staphylococcal infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Subcutaneous abscess	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Tooth abscess	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Tooth infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Upper respiratory tract infection	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Infections and infestations Urinary tract infection	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Injury, poisoning and procedural complications Incision site complication	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Investigations Blood creatinine increased	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Investigations Breath sounds abnormal	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Investigations Haemoglobin decreased	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Investigations Weight decreased	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	36.4% 4/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Investigations White blood cell count decreased	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Anorexia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	57.1% 4/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Decreased appetite	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Dehydration	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hypercalcaemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	36.4% 4/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hypomagnesaemia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	45.5% 5/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	83.3% 5/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 2/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	42.9% 3/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	80.0% 4/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Back pain	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Myalgia	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	54.5% 6/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	57.1% 4/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Pain in extremity	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Musculoskeletal and connective tissue disorders Shoulder pain	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to central nervous system	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Balance disorder	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Cognitive disorder	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Coordination abnormal	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Dizziness	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Dysarthria	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Dysgeusia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Headache	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	36.4% 4/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Hypoaesthesia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Memory impairment	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Mental impairment	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Neuropathy	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Neuropathy peripheral	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Paraesthesia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Restless legs syndrome	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Speech disorder	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Nervous system disorders Tremor	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Anxiety	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Confusional state	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Depression	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Insomnia	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Mental status changes	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Psychiatric disorders Personality change	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Bladder pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Haematuria	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Haemorrhage urinary tract	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Incontinence	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Micturition urgency	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Pollakiuria	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Renal and urinary disorders Proteinuria	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Reproductive system and breast disorders Pelvic discomfort	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Allergic cough	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Cough	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Dysphonia	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	36.4% 4/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	42.9% 3/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Dyspnoea exacerbated	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	57.1% 4/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Hiccups	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Pharyngolaryngeal pain	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Pleural rub	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Pulmonary haemorrhage	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Respiratory, thoracic and mediastinal disorders Sinus congestion	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Acne	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Alopecia	33.3% 2/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	36.4% 4/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	66.7% 4/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Dermatitis acneiform	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	25.0% 1/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	42.9% 3/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	60.0% 3/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	100.0% 6/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	42.9% 3/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Erythema	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 2/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Exfoliative rash	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	75.0% 3/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	42.9% 3/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Hyperhidrosis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Nail disorder	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Pain of skin	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Palmar erythema	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Pruritus	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	85.7% 6/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	60.0% 3/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	50.0% 3/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Rash	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	27.3% 3/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	40.0% 2/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Rash erythematous	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	18.2% 2/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Rash follicular	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Rash generalised	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Rash pruritic	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	20.0% 1/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Skin fissures	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	28.6% 2/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Skin lesion	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Skin and subcutaneous tissue disorders Skin ulcer	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	14.3% 1/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Deep vein thrombosis	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Flushing	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Hot flush	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	9.1% 1/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.
Vascular disorders Thrombosis	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/11 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/4 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/7 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	0.00% 0/5 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.	16.7% 1/6 • First dose through 30 days after last dose; maximum time on treatment was 322 days. The table of Other Adverse Events summarizes non-serious occurrences of adverse events that exceeded a 5% frequency in any treatment arm.

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